Implantation of repair chords in the heart

ABSTRACT

Apparatus is provided, including first and second longitudinal members coupled at respective first portions thereof to tissue surrounding the ventricle. The first portion of at least the first longitudinal member is coupled to a tissue anchor, and respective second portions of the first and second longitudinal members are coupled to respective first and second leaflets of a cardiac valve. The longitudinal members are arranged with respect to the tissue anchor and the portion of tissue surrounding the ventricle in a manner which facilitates adjustment of a degree of tension of the first and second longitudinal members to draw the first and second leaflets together. A longitudinal-member-coupling device is coupled to the first and second longitudinal members, and is advanceable toward a ventricular surface of the first and second leaflets, and responsively to draw together the first and second longitudinal members. Other applications are also described.

CROSS REFERENCE TO RELATED APPLICATION

The present application is a US national phase application ofPCT/IL2010/000357 to Maisano et al., entitled, “Implantation of repairchords in the heart,” filed May 4, 2010, which published as WO 10/128502and which is:

a) a continuation-in-part of and claims the priority from U.S. patentapplication Ser. No. 12/435,291 to Maisano et al., entitled: “Adjustablerepair chords and spool mechanism therefor,” filed May 4, 2009, whichissued as U.S. Pat. No. 8,147,542; and

b) a continuation-in-part of and claims the priority from U.S. patentapplication Ser. No. 12/548,991 to Maisano et al., entitled,“Implantation of repair chords in a heart,” filed Aug.27, 2009, whichissued as U.S. Pat. No. 8,808,368.

All of these applications are assigned to the assignee of the presentapplication and are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to valve and chordeae tendineaerepair. More specifically, the present invention relates to repair of anatrioventricular valve and associated chordeae tendineae of a patient.

BACKGROUND OF THE INVENTION

Ischemic heart disease causes mitral regurgitation by the combination ofischemic dysfunction of the papillary muscles, and the dilatation of theleft ventricle that is present in ischemic heart disease, with thesubsequent displacement of the papillary muscles and the dilatation ofthe mitral valve annulus.

Dilation of the annulus of the mitral valve prevents the valve leafletsfrom fully coapting when the valve is closed. Mitral regurgitation ofblood from the left ventricle into the left atrium results in increasedtotal stroke volume and decreased cardiac output, and ultimate weakeningof the left ventricle secondary to a volume overload and a pressureoverload of the left atrium.

Chronic or acute left ventricular dilatation can lead to papillarymuscle displacement with increased leaflet tethering due to tension onchordeae tendineae, as well as annular dilatation.

U.S. Pat. No. 7,431,692 to Zollinger et al., which is incorporatedherein by reference, describes an adjustable support pad for adjustablyholding a tensioning line used to apply tension to a body organ. Theadjustable support pad can include a locking mechanism for preventingslidable movement of the tensioning element in one or both directions.The locking mechanism may include spring-loaded locks, rotatablecam-like structures, and/or rotatable spool structures. The adjustablesupport pad may be formed from rigid, semi-rigid, and/or flexiblematerials, and may be formed to conform to the outer surface of a bodyorgan. The adjustable support pad can be configured to adjustably holdone or more separate tensioning lines, and to provide for independentadjustment of one or more tensioning lines or groups thereof.

US Patent Application Publication 2007/0118151 to Davidson, which isincorporated herein by reference, describes a method and system toachieve leaflet coaptation in a cardiac valve percutaneously by creationof neochordeae to prolapsing valve segments. This technique isespecially useful in cases of ruptured chordeae, but may be utilized inany segment of prolapsing leaflet. The technique described herein hasthe additional advantage of being adjustable in the beating heart. Thisallows tailoring of leaflet coaptation height under various loadingconditions using image-guidance, such as echocardiography. This offersan additional distinct advantage over conventional open-surgeryplacement of artificial chordeae. In traditional open surgical valverepair, chord length must be estimated in the arrested heart and may ormay not be correct once the patient is weaned from cardiopulmonarybypass. The technique described below also allows for placement ofmultiple artificial chordeae, as dictated by the patient'spathophysiology.

U.S. Pat. No. 6,626,930 to Allen et al., which is incorporated herein byreference, describes apparatus and method for the stabilization andfastening of two pieces of tissue. A single device may be used to bothstabilize and fasten the two pieces of tissue, or a separate stabilizingdevice may be used in conjunction with a fastening device. Thestabilizing device may comprise a probe with vacuum ports and/ormechanical clamps disposed at the distal end to approximate the twopieces of tissue. After the pieces of tissue are stabilized, they arefastened together using sutures or clips. One exemplary embodiment of asuture-based fastener comprises a toggle and suture arrangement deployedby a needle, wherein the needle enters the front side of the tissue andexits the blind side. In a second exemplary embodiment, the suture-basedfastener comprises a needle connected to a suture. The needle enters theblind side of the tissue and exits the front side. The suture is thentied in a knot to secure the pieces of tissue. One example of aclip-based fastener comprises a spring-loaded clip having two arms withtapered distal ends and barbs. The probe includes a deployment mechanismwhich causes the clip to pierce and lockingly secure the two pieces oftissue.

U.S. Pat. No. 6,629,534 to St. Goar et al., which is incorporated hereinby reference, describes methods, devices, and systems are provided forperforming endovascular repair of atrioventricular and other cardiacvalves in the heart. Regurgitation of an atrioventricular valve,particularly a mitral valve, can be repaired by modifying a tissuestructure selected from the valve leaflets, the valve annulus, the valvechordeae, and the papillary muscles. These structures may be modified bysuturing, stapling, snaring, or shortening, using interventional toolswhich are introduced to a heart chamber. Preferably, the tissuestructures will be temporarily modified prior to permanent modification.For example, opposed valve leaflets may be temporarily grasped and heldinto position prior to permanent attachment.

U.S. Pat. No. 6,752,813 to Goldfarb et al., which is incorporated hereinby reference, describes methods and devices for grasping, and optionalrepositioning and fixation of the valve leaflets to treat cardiac valveregurgitation, particularly mitral valve regurgitation. Such graspingwill typically be atraumatic providing a number of benefits. Forexample, atraumatic grasping may allow repositioning of the devicesrelative to the leaflets and repositioning of the leaflets themselveswithout damage to the leaflets. However, in some cases it may benecessary or desired to include grasping which pierces or otherwisepermanently affects the leaflets. In some of these cases, the graspingstep includes fixation.

US Patent Application Publication 2003/0105519 to Fasol et al., which isincorporated herein by reference, describes artificial chordeae having astrand member and a first and second pair of sutures at eitherlongitudinal end of the strand member. The artificial chordeae ispreferably a unitary unit, formed from inelastic flexible material. Inone embodiment, the artificial chordeae comprises multiple strandmembers joined together at a joined end. Different sized artificialchordeae are provided sized to fit the patient's heart. Theappropriately sized artificial chordeae is chosen by using a chordeaesizing gauge having a shaft and a transverse member, to measure thespace within the patient's heart where the artificial chordeae isattached.

The following patents and patent application publications may be ofinterest:

PCT Patent Application Publication WO 07/136,783 to Cartledge et al.

U.S. Pat. No. 4,917,698 to Carpentier et al.

U.S. Pat. No. 5,306,296 to Wright et al.

U.S. Pat. No. 6,332,893 to Mortier et al.

U.S. Pat. No. 6,569,198 to Wilson et al.

U.S. Pat. No. 6,619,291 to Hlavka et al.

U.S. Pat. No. 6,764,510 to Vidlund et al.

U.S. Pat. No. 7,004,176 to Lau

U.S. Pat. No. 7,101,395 to Tremulis et al.

U.S. Pat. No. 7,175,660 to Cartledge et al.

U.S. Pat. No. 7,297,150 to Cartledge et al.

US Patent Application Publication 2003/0050693 to Quijano et al

US Patent Application Publication 2003/0167062 to Gambale et al.

US Patent Application Publication 2004/0024451 to Johnson et al.

US Patent Application Publication 2004/0148021 to Cartledge et al.

US Patent Application Publication 2004/0236419 to Milo

US Patent Application Publication 2005/0171601 to Cosgrove et al.

US Patent Application Publication 2005/0216039 to Lederman

US Patent Application Publication 2005/0288781 to Moaddeb et al.

US Patent Application Publication 2007/0016287 to Cartledge et al.

US Patent Application Publication 2007/0080188 to Spence et al.

US Patent Application Publication 2009/0177266 to Powell et al.

The following articles may be of interest:

O'Reilly S et al., “Heart valve surgery pushes the envelope,” MedtechInsight 8(3): 73, 99-108 (2006)

Dieter R S, “Percutaneous valve repair: Update on mitral regurgitationand endovascular approaches to the mitral valve,” Applications inImaging, Cardiac Interventions, Supported by an educational grant fromAmersham Health pp. 11-14 (2003)

SUMMARY OF THE INVENTION

In some applications of the present invention, apparatus is providedcomprising adjustable repair chords and a delivery tool for implantationthereof. The apparatus typically comprises subvalvular apparatus. Therepair chords comprise one or more longitudinal members (e.g., sutures,wires, or elongate tensioning coils) which are coupled at respectivefirst end portions thereof to an adjusting mechanism. In someapplications of the present invention, the repair chords function asartificial chordeae tendineae. In other applications of the presentinventions, the repair chords are used to adjust a distance between twoportions of the ventricular wall.

In some applications of the present invention, the adjusting mechanismcomprises a spool assembly. The spool assembly comprises a housing,which houses a spool to which first end portions, e.g., a distalportion, of the longitudinal members are coupled. The housing is coupledto a tissue anchor, which facilitates implantation of the spool assemblyin a first portion of tissue of the heart which faces and surrounds theventricular lumen, such as a papillary muscle or a first portion of aventricular wall of the heart. Second end portions, e.g., a proximalportion, of the longitudinal members are coupled (e.g., tied, sutured,clipped, or otherwise fastened) to a second portion of tissue whichfaces and surrounds the ventricle, such as a leaflet of anatrioventricular valve (e.g., a mitral valve or a tricuspid valve) or asecond portion of the ventricular wall.

Once the second ends of the longitudinal members are coupled to thesecond portion of tissue of the heart that faces and surrounds theventricle, the spool is rotated in order to adjust a length of thelongitudinal member. During the rotation of the spool in a firstdirection thereof, the longitudinal member is wound around the spoolthereby shortening and tensioning the longitudinal member. As a result,the ends of the longitudinal member coupled to the second portion ofheart tissue, and consequently the second portion of tissue, are pulledtoward the adjusting mechanism at the first portion of tissue. Thus, forapplications in which the repair chord functions as an artificialchordea tendinea, the longitudinal member replaces slackened nativechordeae tendineae and improves function of or restores normal functionto the atrioventricular valve. For applications in which the repairchord is coupled to two portions of the ventricular wall, the twoportions are drawn together, thereby restoring the dimensions of theheart wall to physiological dimensions, and drawing the leaflets towardone another.

In some applications of the present invention, the adjusting mechanismcomprises a reversible locking mechanism which facilitates bidirectionalrotation of the spool in order to effect both tensioning and relaxing ofthe longitudinal member. That is, the spool is wound in one direction inorder to tighten the longitudinal member and adjust a length of thelongitudinal member that is between the first and second portions oftissue, and in an opposite direction in order to slacken thelongitudinal member. Thus, the spool adjusting mechanism facilitatesbidirectional adjustment of the repair chord.

In some applications of the present invention, the adjustable repairchords are implanted during an open-heart procedure. In theseapplications, the delivery tool comprises a handle and a multilumenshaft that is coupled at a distal end thereof to the adjustingmechanism. The delivery tool functions to advance the adjustingmechanism to the first portion of tissue, implant the adjustingmechanism at the first portion of tissue, and effect adjustment of therepair chord by effecting rotation of the spool. The multilumen shaftdefines a primary lumen which houses an elongate torque-delivering tooland is slidable with respect to a shaft of the elongatetorque-delivering tool. For applications in which the repair chordfunctions as an artificial chordea tendinea, prior to implantation ofthe adjusting mechanism, the distal portion of the delivery tool and theadjusting mechanism coupled thereto are advanced between the leaflets ofthe atrioventricular valve and into the ventricle toward the firstportion of tissue. During the implantation of the adjusting mechanism,the multilumen shaft is disposed around the portion of thetorque-delivering tool that is positioned in the ventricle. Prior to thesubsequent rotation of the spool, the multilumen shaft is pulledproximally with respect to the torque-delivering tool that is left inplace during the pulling. The multilumen shaft is pulled such that adistal end thereof is disposed proximal to the valve and in the atrium.

The incision made in the heart is then closed around the delivery tooland the heart resumes its normal function during the adjustment of thelength of the artificial chordea. The retracting of the multilumen shaftreduces a diameter of the delivery tool at the portion thereof that isdisposed between the leaflets of the valve. Such reducing of thediameter reduces the interference of the portion of the delivery tool onthe beating heart valve and the adjustment of the artificial chordea isperformed with minimal interference to the valve by the delivery tool.

In other applications of the present invention, the adjustable repairchords are implanted during a transcatheter procedure. In theseapplications, the delivery tool typically comprises a surrounding shaft,which is configured to be slidable over and along a central shaft, suchthat the surrounding shaft surrounds a portion of the central shaft. Thedelivery tool is advanced through a sheath and into the left ventricle.All or a portion of the delivery tool is rotated in order to screw theanchor of the spool assembly into the first portion of tissue, e.g.,tissue of a papillary muscle, tissue at a base of the papillary muscle,or tissue at a wall of the heart of the patient that surrounds theventricle, such as the free wall or the septum.

The surrounding shaft is withdrawn proximally into the atrium, whilemaintaining the distal end of the central shaft in place and within theventricle. The surrounding shaft is advanced distally between theleaflets. While the distal end of the central shaft is maintained inplace and within the ventricle, the surrounding shaft is used to engageone or more of the leaflets with one or more leaflet-engaging elements.In order to couple the leaflet-engaging elements to the leaflet, ifnecessary the surgeon may manipulate the surrounding shaft (e.g., pushthe shaft against the leaflet, and/or slightly withdraw and advance theshaft one or more times). Alternatively or additionally, the naturalmotion of the leaflet may engage the leaflet with the leaflet-engagingelements. It is noted that before and after this engagement occurs, theleaflets are free to open and close during the natural cardiac cycle.

In some applications of the present invention, apparatus and methoddescribed herein may be used for providing artificial chordeae tendineaein a left ventricle of the heart and effecting adjustment thereof. Insome applications of the present invention, apparatus and methoddescribed herein may be used for providing artificial chordeae tendineaein a right ventricle of the heart and effecting adjustment thereof. Insome applications of the present invention, apparatus and methoddescribed herein may be used for providing a system to adjust a lengthbetween two portions of the heart wall.

There is therefore provided, in accordance with some applications of thepresent invention, a method, including:

positioning, at an intraventricular site of a ventricle of a patient, aspool coupled to a first end portion of a longitudinal member; and

coupling a second end portion of the longitudinal member to a portion oftissue facing a lumen of the ventricle.

In some applications of the present invention, positioning the spoolincludes transcatheterally advancing the spool toward theintraventricular site.

In some applications of the present invention, positioning the spoolincludes advancing the spool toward the intraventricular site during anopen-heart procedure.

In some applications of the present invention, positioning the spoolincludes advancing the spool toward the intraventricular site during aminimally-invasive procedure.

In some applications of the present invention, coupling the second endportion of the longitudinal member to the portion of tissue facing theventricular lumen includes coupling the second end portion of thelongitudinal member to a leaflet of an atrioventricular valve of thepatient.

In some applications of the present invention, positioning the spoolincludes implanting the spool at the intraventricular site.

In some applications of the present invention, implanting the spool inthe intraventricular site includes suturing the spool to theintraventricular site.

In some applications of the present invention, the spool is coupled to atissue anchor, and implanting the spool at the intraventricular siteincludes implanting the tissue anchor in tissue of the ventricle suchthat a distal end of the tissue anchor is disposed within the tissue ofthe ventricle and does not extend beyond a pericardium of a heart of thepatient.

In some applications of the present invention,

the tissue facing the lumen of the ventricle is at least one leaflet ofan atrioventricular valve of the patient,

the longitudinal member is an artificial chordea tendinea, and the spoolis coupled to the first end portion of the artificial chordea tendinea,and

implanting the spool includes:

-   -   advancing, between leaflets of the atrioventricular valve and        into the ventricle, at least a shaft of a delivery tool, to        which shaft the spool is removably coupled, and implanting the        spool at the intraventricular site; and    -   while the shaft remains coupled to the spool after implanting        the spool, coupling, using a coupling element holder of the        delivery tool, at least one leaflet-engaging element to the at        least one leaflet, a second end portion of the artificial        chordea tendinea is coupled to the at least one leaflet-engaging        element.

In some applications of the present invention, implanting the spool atthe intraventricular site includes implanting the spool at a papillarymuscle of the ventricle of the patient.

In some applications of the present invention, implanting the spool atthe intraventricular site includes implanting the spool at an inner wallof the ventricle of the patient.

In some applications of the present invention, advancing the at leastthe shaft includes transcatheterally advancing the at least the shaft.

In some applications of the present invention, coupling the at least oneleaflet-engaging element to the at least one leaflet includes couplingthe at least one leaflet-engaging element to exactly one leaflet.

In some applications of the present invention, coupling the at least oneleaflet-engaging element to the at least one leaflet while the shaftremains coupled to the spool includes using the shaft to provide areference force to the leaflet-engaging element.

In some applications of the present invention, using the couplingelement holder of the delivery tool includes sliding the couplingelement holder with respect to the shaft.

In some applications of the present invention, the at least oneleaflet-engaging element is a butterfly clip, which includes a pluralityof petals arranged around a needle, and coupling includes penetratingthe needle and petals through a ventricular surface of the at least oneleaflet until the needle and petals emerge from an atrial surface of theat least one leaflet, and the petals unfold and couple the clip to theat least one leaflet.

In some applications of the present invention, the method furtherincludes adjusting, from a site outside of a body of the patient, alength of the artificial chordea tendinea.

In some applications of the present invention,

the spool is coupled to first end portions of respective first andsecond artificial chordeae tendineae,

coupling the at least one leaflet-engaging element includes coupling atleast first and second leaflet-engaging elements to respective first andsecond leaflets, and

second end portions of the respective first and second artificialchordeae tendineae are coupled to respective first and secondleaflet-engaging elements.

In some applications of the present invention, coupling theleaflet-engaging elements includes using the artificial chordeaetendineae to draw together the first and second leaflets.

In some applications of the present invention, drawing together includesdrawing together the first and second leaflets using a bead throughwhich the artificial chordeae tendineae pass.

In some applications of the present invention, the at least oneleaflet-engaging element is a clip, and coupling includes clamping theclip on the at least one leaflet such that the clip engages atrial andventricular surfaces of the leaflet.

In some applications of the present invention, the clip includes twoclip jaws, and clamping includes holding the clip jaws within respectivetool jaws of the coupling element holder, and opening and closing theclip jaws using the tool jaws.

In some applications of the present invention, the at least oneleaflet-engaging element is a non-continuous ring, and coupling includescoupling the non-continuous ring to the at least one leaflet.

In some applications of the present invention, coupling thenon-continuous ring to the at least one leaflet includes initiallyholding the non-continuous ring in an extended position using adeforming rod, positioning the non-continuous ring in a vicinity of theat least one leaflet, and thereafter separating the deforming rod fromthe non-continuous ring such that the non-continuous ring assumes anannular position coupled to the at least one leaflet.

In some applications of the present invention, the at least oneleaflet-engaging element is at least one hook, and coupling includespuncturing the at least one leaflet with the at least one hook.

In some applications of the present invention, puncturing the at leastone leaflet with the at least one hook includes sliding the at least onehook proximally to an atrial surface of the at least one leaflet andsubsequently puncturing the leaflet by sliding the at least one hookdistally.

In some applications of the present invention, puncturing the at leastone leaflet includes sliding the at least one hook proximally to anatrial surface of the leaflet and allowing the at least one leaflet toengage the at least one hook responsively to beating of the leaflet.

In some applications of the present invention,

positioning the spool includes positioning the spool at a first portionof tissue facing the ventricular lumen,

coupling the second end portion of the longitudinal member to theportion of tissue includes coupling the second end portion of thelongitudinal member to a second portion of tissue facing the ventricularlumen, and

the method further includes:

-   -   rotating the spool,    -   by the rotating of the spool, winding a portion of the        longitudinal member around the spool,    -   by the winding of the portion, shortening a length of the        longitudinal member, and    -   by the shortening of the length of the longitudinal member,        drawing together the first and second portions of the tissue        facing the ventricular lumen of the patient.

In some applications of the present invention, the method includesadjusting, from a site outside of a body of the patient, the length ofthe longitudinal member.

In some applications of the present invention,

positioning the spool at the first portion of tissue includes implantingthe spool at a papillary muscle of a left ventricle of the patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a leaflet of a mitral valve of the patient, and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the leaflet toward the papillarymuscle.

In some applications of the present invention,

positioning the spool at the first portion of tissue includes implantingthe spool at a papillary muscle of a right ventricle of the patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a leaflet of a tricuspid valve of the patient,and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the leaflet toward the papillarymuscle.

In some applications of the present invention,

positioning the spool at the first portion of tissue includes implantingthe spool at a first portion of tissue of an inner wall of a leftventricle of the patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a leaflet of a mitral valve of the patient, and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the leaflet toward the first portionof tissue of the inner wall of the ventricle.

In some applications of the present invention,

positioning the spool at the first portion of tissue includes implantingthe spool at a first portion of an inner wall of a right ventricle ofthe patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a leaflet of a tricuspid valve of the patient,and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the leaflet toward the first portionof tissue of the inner wall of the ventricle.

In some applications of the present invention,

positioning the spool at the first portion of tissue includes implantingthe spool at a first portion of an inner wall of the ventricle of thepatient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a second portion of the inner wall of theventricle of the patient, and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the first and second portions oftissue of the inner wall of the ventricle toward one another.

In some applications of the present invention, the method includesadjusting, from a site outside of a body of the patient, the length ofthe longitudinal member.

In some applications of the present invention,

positioning the spool at the first portion of tissue includes implantingthe spool at a papillary of the ventricle of the patient,

coupling the second end portion of the longitudinal member to the secondportion of tissue includes coupling the second end portion of thelongitudinal member to a portion of an inner wall of the ventricle ofthe patient, and

drawing together the first and second portions of the tissue facing theventricular lumen includes drawing the papillary muscle and the portionof tissue of the inner wall of the ventricle toward one another.

In some applications of the present invention, positioning the spoolcoupled to the first end portion of the longitudinal member includespositioning a spool coupled to at least first and second longitudinalmembers at respective first end portions thereof, each longitudinalmember having respective second end portions thereof, and the methodfurther includes:

coupling the second end portion of the first longitudinal member to afirst portion of heart tissue facing the ventricular lumen;

coupling the second end portion of the second longitudinal member to asecond portion of heart tissue facing the ventricular lumen; and

drawing the first and second portions of heart tissue toward oneanother.

In some applications of the present invention, positioning the spoolincludes implanting the spool at a papillary muscle.

In some applications of the present invention, positioning the spoolincludes implanting the spool at a portion of tissue of an inner wall ofthe ventricle facing the ventricular lumen.

In some applications of the present invention,

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a first portion of an inner wall of theventricle,

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a second portion of an inner wall of theventricle, and

drawing the first and second portions of heart tissue toward one anotherincludes drawing together the first and second portions of the innerwall of the ventricle.

In some applications of the present invention,

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a portion of an inner wall of theventricle,

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a papillary muscle of the ventricle, and

drawing the first and second portions of heart tissue toward one anotherincludes drawing the portion of the inner wall of the ventricle and thepapillary muscle toward one another.

In some applications of the present invention,

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a leaflet of an atrioventricular valve,

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a papillary muscle of the ventricle, and

drawing the first and second portions of heart tissue toward one anotherincludes drawing the leaflet and the papillary muscle toward oneanother.

In some applications of the present invention,

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a leaflet of an atrioventricular valve,

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a portion of an inner wall of theventricle, and

drawing the first and second portions of heart tissue toward one anotherincludes drawing the leaflet and the portion of the inner wall towardone another.

In some applications of the present invention,

coupling the second end portion of the first longitudinal member to thefirst portion of tissue includes coupling the second end portion of thefirst longitudinal member to a first leaflet of an atrioventricularvalve,

coupling the second end portion of the second longitudinal member to thesecond portion of tissue includes coupling the second end portion of thesecond longitudinal member to a second leaflet of the atrioventricularvalve, and

drawing the first and second portions of heart tissue toward one anotherincludes drawing the first and second leaflets toward one another.

In some applications of the present invention, the method includesadvancing the spool toward the intraventricular site by advancing aportion of a delivery tool that is reversibly coupled to the spoolbetween leaflets of an atrioventricular valve having at least first andsecond leaflets thereof, and positioning the spool at theintraventricular site includes manipulating the delivery tool toposition the spool at the intraventricular site.

In some applications of the present invention, the method includes,after positioning the spool:

decoupling the delivery tool from the spool,

removing the delivery tool from the ventricle, and

subsequently to the removing, accessing the spool at theintraventricular site.

In some applications of the present invention, accessing the spoolincludes recoupling the delivery tool to the spool by advancing thedelivery tool along at least one guide wire coupled to the spool.

In some applications of the present invention, accessing the spoolincludes coupling a torque-delivering tool to the spool by advancing thetorque-delivering tool through an elongate tube coupled at a first endthereof to the spool and at second end thereof to a portion ofsubcutaneous tissue of the patient.

In some applications of the present invention, the method furtherincludes, after coupling the second end portion of the longitudinalmember to the portion of tissue facing the ventricular lumen:

sliding a shaft of the delivery tool with respect to a torque-deliveringtool of the delivery tool, and sliding a proximal portion of the shaftinto a lumen of a handle portion of the delivery tool; and

subsequently to the sliding, rotating the spool.

In some applications of the present invention, sliding the shaftincludes:

sliding the shaft until a distal portion of the shaft is disposedproximally to the atrioventricular valve, and

responsively, reducing a diameter of the portion of the delivery tooldisposed between the leaflets of the valve.

In some applications of the present invention, reducing the diameter ofthe portion of the delivery tool disposed between the leaflets of thevalve includes reducing the diameter to between 0.8 mm and 1.5 mm.

In some applications of the present invention,

positioning the spool includes positioning the spool coupled to amechanical locking element having a surface coupled to the lower surfaceof the rotatable structure, and

the method further includes:

-   -   advancing an elongate tool through a channel provided by the        spool;    -   unlocking the spool from the mechanical locking element by        pushing a depressible portion of the surface of the locking        element;    -   responsively to the pushing of the depressible portion,        dislodging a protrusion protruding out of a plane of the surface        of the mechanical element from within a recess defined by the        spool; and    -   rotating the spool.

In some applications of the present invention,

during a first period:

-   -   pushing the depressible portion includes maintaining the        protrusion in a position in which it is dislodged from the        recess; and    -   rotating the spool;

the method further includes, during a second period:

-   -   removing the elongate tool from within the channel and        facilitating

positioning of the protrusion in the recess; and

-   -   restricting rotation of the spool.

There is additionally provided, in accordance with some applications ofthe present invention apparatus including:

a delivery tool including:

-   -   a handle portion defining a handle lumen; and    -   a shaft (a) being slidable with respect to the handle, and (b)        having a proximal portion thereof being slidable into the handle        lumen during proximal sliding of the shaft;

a spool removably couplable to the distal end of the delivery tool andconfigured to be implanted in an intraventricular site of a ventricle ofa patient; and

at least one longitudinal member having opposite first and second endportions, the first end portion being coupled to the spool and thesecond end portion configured to be coupled to a first portion of hearttissue that surrounds a ventricular space of the ventricle of thepatient, the longitudinal member configured to be wound around the spoolin response to rotation of the spool, and, responsively, to draw thesecond end portion of the longitudinal member and the first portion ofheart tissue toward the first end portion of the longitudinal member.

In some applications of the present invention, the shaft is shaped toprovide at least one secondary lumen configured for housing a section ofthe longitudinal member that is between the first and second endportions thereof.

In some applications of the present invention, the longitudinal memberincludes expanded polytetrafluoroethylene (ePTFE).

In some applications of the present invention, at least a portion of thelongitudinal member is shaped to define a coil, and the coil isconfigured to apply a tensioning force to the first portion of hearttissue.

In some applications of the present invention, the longitudinal memberis coated with polytetrafluoroethylene.

In some applications of the present invention, the apparatus includes alocking mechanism coupled to the spool and configured to restrictrotation of the spool.

In some applications of the present invention,

the at least one longitudinal member includes at least first and secondlongitudinal members having respective first and second end portionsthereof,

the first end portions of the first and second longitudinal members arecoupled to the spool,

the second end portion of the first longitudinal member is configured tobe coupled to a leaflet of an atrioventricular valve,

the second end portion of the second longitudinal member is configuredto be coupled to a portion of tissue of an inner wall of the ventricle,and

in response to rotation of the spool, the first and second longitudinalmembers are tightened and pull the leaflet toward the portion of tissueof the inner wall.

In some applications of the present invention,

the at least one longitudinal member includes at least first and secondlongitudinal members having respective first and second end portionsthereof,

the first end portions of the first and second longitudinal members arecoupled to the spool,

the second end portion of the first longitudinal member is configured tobe coupled to a leaflet of an atrioventricular valve,

the second end portion of the second longitudinal member is configuredto be coupled to a papillary muscle of the ventricle, and

in response to rotation of the spool, the first and second longitudinalmembers are tightened and pull the leaflet toward the papillary muscle.

In some applications of the present invention,

the at least one longitudinal member includes at least first and secondlongitudinal members having respective first and second end portionsthereof,

the first end portions of the first and second longitudinal members arecoupled to the spool,

the second end portion of the first longitudinal member is configured tobe coupled to a first portion of tissue of an inner wall of theventricle,

the second end portion of the second longitudinal member is configuredto be coupled to a second portion of tissue of the inner wall of theventricle, and

in response to rotation of the spool, the first and second longitudinalmembers are tightened and pull the first and second portions of tissueof the inner wall toward one another.

In some applications of the present invention, the apparatus includes anelongate tube coupled at a first end to the spool and at a second endthereof to subcutaneous tissue of the patient, the elongate tube isconfigured to facilitate accessing of a torque-delivering tool to thespool following (a) the implantation of the spool at theintraventricular site and (b) subsequent removal of the delivery tool.

In some applications of the present invention, the spool is configuredto be coupled to a second portion of heart tissue that surrounds theventricular space, and, in response to the rotation of the spool, thelongitudinal member is configured to draw the first and second portionsof heart tissue toward one another.

In some applications of the present invention,

the first portion of heart tissue includes a first portion of an innerwall of the ventricle,

the second end portion of the longitudinal member is configured to becoupled to the first portion of the inner wall of the ventricle, and

in response to the rotation of the spool, the longitudinal member isconfigured to draw the first portion of the inner wall of the ventricletoward the second portion of heart tissue.

In some applications of the present invention,

the first portion of heart tissue includes a leaflet of a mitral valveof the patient,

the second end portion of the longitudinal member is configured to becoupled to the leaflet of the mitral valve of the patient,

the second portion of heart tissue includes tissue of a papillary muscleof a left ventricle,

the spool is configured to be implanted in the tissue of the papillarymuscle of the left ventricle, and

the spool is configured to adjust a length of the longitudinal memberbetween the papillary muscle and the leaflet of the mitral valve.

In some applications of the present invention,

the first portion of heart tissue includes a leaflet of a mitral valveof the patient,

the second end portion of the longitudinal member is configured to becoupled to the leaflet of the mitral valve of the patient,

the second portion of heart tissue includes a second portion of an innerwall of a left ventricle,

the spool is configured to be coupled to the second portion of the innerwall of the left ventricle, and

the spool is configured to adjust a length of the longitudinal memberbetween the second portion of the inner wall and the leaflet of themitral valve.

In some applications of the present invention,

the first portion of heart tissue includes a leaflet of a tricuspidvalve of the patient,

the second end portion of the longitudinal member is configured to becoupled to the leaflet of the tricuspid valve of the patient,

the second portion of heart tissue includes tissue of a papillary muscleof a right ventricle,

the spool is configured to be implanted in the tissue of the papillarymuscle of the right ventricle, and

the spool is configured to adjust a length of the longitudinal memberbetween the papillary muscle and the leaflet of the tricuspid valve.

In some applications of the present invention,

the first portion of heart tissue includes a leaflet of a tricuspidvalve of the patient,

the second end portion of the longitudinal member is configured to becoupled to the leaflet of the tricuspid valve of the patient,

the second portion of heart tissue includes a second portion of an innerwall of a right ventricle,

the spool is configured to be coupled to the second portion of the innerwall of the right ventricle, and

the spool is configured to adjust a length of the longitudinal memberbetween the second portion of the inner wall and the leaflet of thetricuspid valve.

In some applications of the present invention, the apparatus includes atleast one guide wire coupled to the spool, and, subsequently to theimplantation of the spool, the delivery tool is configured to be:

decoupled from the spool and removed from the ventricle, and

advanceable along the guide wire.

In some applications of the present invention, the guide wire isconfigured to facilitate access of a torque-delivering tool to the spoolfollowing the implantation of the spool at the intraventricular site.

In some applications of the present invention, the apparatus includes atorque-delivering tool,

the shaft is shaped to define at least a primary lumen,

the torque-delivering tool is disposed in the primary lumen and iscoupled at a proximal end thereof to the handle, and

the shaft is slidable with respect to the torque-delivering tool.

In some applications of the present invention, the delivery tool isconfigured to be advanceable between leaflets of an atrioventricularvalve of the patient, and the shaft is slidable with respect to thetorque-delivering tool in a manner that reduces a diameter of a portionof the delivery tool that is disposed between the leaflets of the valve.

In some applications of the present invention, the handle lumen has ahandle-lumen-length of between 50 mm and 100 mm, and the shaft isslidable in a first direction thereof to advance the proximal portionthereof into the lumen of the delivery tool.

In some applications of the present invention, the distal portion of thetorque-delivering tool is configured to be positioned within theventricular space of the heart and defines a torque-delivering toollength at the distal portion of between 50 mm and 100 mm, and a ratio ofthe handle-lumen-length and the torque-delivering tool length at thedistal portion is between 0.7:1 and 1.3:1.

In some applications of the present invention,

the first portion of heart tissue includes an atrioventricular valvehaving at least first and second leaflets thereof,

the at least one longitudinal member includes at least first and secondlongitudinal members having respective first and second end portionsthereof,

the first end portions of the first and second longitudinal members arecoupled to the spool,

the second end portion of the first longitudinal member is configured tobe coupled to the first leaflet of the valve,

the second end portion of the second longitudinal member is configuredto be coupled to the second leaflet of the valve, and

in response to rotation of the spool, the first and second longitudinalmembers are tightened and pull on the respective second end portionsthereof toward the spool.

In some applications of the present invention, in response to rotationof the spool in a first direction thereof, the respective first endportions of the first and second longitudinal members are configured tobe wound around the spool, and, responsively, to pull the respectivesecond end portions of the first and second longitudinal members towardthe spool, and responsively to draw the first and second leaflets towardone another.

In some applications of the present invention, the apparatus includes ahousing surrounding the spool, the housing being coupled in part to acap having a surface that is disposed in parallel with the lower surfaceof the spool, and the depressible portion is disposed between the lowersurface of the spool and the cap.

In some applications of the present invention, the apparatus includes ahousing surrounding the spool, the housing being shaped to define arecessed portion thereof configured to receive the protrusion during theresting state of the mechanical element.

In some applications of the present invention, the apparatus includes atorque-delivering tool disposed within a primary lumen of the shaft, thetorque-delivering tool is coupled at a distal end thereof to theelongate rotation tool, and the torque-delivering tool is configured tofacilitate rotation of the spool by facilitating rotation of theelongate tool.

There is yet further provided, in accordance with some applications ofthe present invention, apparatus, including:

a rotatable structure having a first end shaped to define a firstopening, and a second end shaped to define a second opening, therotatable structure being shaped to define a channel extending from thefirst opening to the second opening, the channel being configured forpassage therethrough of an elongate tool, and the second end of thestructure having a lower surface thereof shaped to:

-   -   provide at least a portion thereof having a circumference, and    -   define one or more recesses at locations along the        circumference; and

a mechanical element having a surface coupled to the lower surface ofthe rotatable structure, the mechanical element being shaped to provide:

-   -   a protrusion protruding out of a plane of the surface of the        mechanical element, the protrusion being disposed within one of        the recesses during a resting state of the mechanical element,        in a manner that restricts rotation of the rotatable structure,        and    -   a depressible portion coupled to the protrusion, the depressible        portion being disposed in communication with the second opening        of the lower surface, and configured to dislodge the protrusion        from within the recess in response to a force applied thereto by        the elongate tool.

In some applications of the present invention,

during a first period:

-   -   the elongate tool is configured to maintain the protrusion in a        position in which it is dislodged from the recess, and    -   the elongate tool is configured to rotate the rotatable        structure, and during a second period:    -   the elongate tool is configured to remove the elongate tool from        the channel and to position the protrusion in the recess, and    -   the rotatable structure is restricted from being rotated.

In some applications of the present invention, the apparatus includes ahousing surrounding the rotatable structure, the housing being coupledin part to a cap having a surface that is disposed in parallel with thelower surface of the rotatable structure, and the depressible portion isdisposed between the lower surface of the rotatable structure and thecap.

In some applications of the present invention, the apparatus includes ahousing surrounding the rotatable structure, the housing being shaped todefine a recessed portion thereof configured to receive the protrusionduring the resting state of the mechanical element.

In some applications of the present invention, the rotatable structureincludes a spool, and the apparatus further includes a longitudinalmember configured to be coupled at at least a first end portion thereofto the spool and to be wrapped around the spool in response to rotationof the spool in a first direction thereof.

In some applications of the present invention,

during a first period:

-   -   the elongate tool is configured to maintain the protrusion in a        position in which it is dislodged from the recess, and    -   the elongate tool is configured to rotate the spool, and

during a second period:

-   -   the elongate tool is configured to remove the elongate tool from        the channel and to position the protrusion in the recess, and    -   the spool is restricted from being rotated.

In some applications of the present invention,

the spool is configured for implantation in a first portion of hearttissue that defines a ventricular lumen of the ventricle of a patient,

the longitudinal member is configured to be coupled at a second endportion thereof to a second portion of heart tissue that defines aventricular lumen of the ventricle of the patent, and

in response to rotation of the spool in a first direction thereof, thelongitudinal member is configured to be wound around the spool, and,responsively, to shorten a distance between the second end portion ofthe longitudinal member and the spool.

There is still further provided, in accordance with some applications ofthe present invention, a method, including:

providing a rotatable structure coupled to a mechanical locking elementhaving a surface coupled to the lower surface of the rotatablestructure;

implanting the rotatable structure in cardiac tissue;

advancing an elongate tool through a channel provided by the rotatablestructure;

unlocking the rotatable structure from the mechanical locking element bypushing a depressible portion of the surface of the locking element;

responsively to the pushing of the depressible portion, dislodging aprotrusion protruding out of a plane of the surface of the mechanicalelement from within a recess defined by the rotatable structure; and

rotating the rotatable structure.

There is additionally provided, in accordance with some applications ofthe present invention, an implant delivery tool for use with an implant,the tool including:

an implant-coupling portion;

an elongate delivery tool shaft having a proximal end thereof and adistal end, the distal end being coupled at a distal end thereof to theimplant-coupling portion; and

a tissue-engaging-device holder coupled along a portion of the shaftbetween the implant-coupling portion and the proximal end of the shaft,the tissue-engaging-device holder being shaped to define at least onecoupling site for coupling the tissue-engaging-device.

In some applications of the present invention, the apparatus includes animplant assembly including at least one longitudinal member coupled at afree end thereof to a tissue-engaging-device.

In some applications of the present invention, the longitudinal memberextends along the shaft toward the tissue-engaging-device holder, andthe tissue-engaging-device holder is shaped to provide a projectionthereof configured for winding excess portions of the longitudinalmember therearound.

There is yet additionally provided, in accordance with some applicationsof the present invention, apparatus, including:

an intraventricular adjusting assembly configured to be implanted in anintraventricular site of a ventricle of a patient;

an elongate coupling tube coupled at a first end thereof to theintraventricular adjusting assembly and at second end thereof to aportion of subcutaneous tissue of the patient; and

an extracardiac tool configured to access the adjusting assembly from asite external to a body of the patient.

There is still yet additionally provided, in accordance with someapplications of the present invention, a method, including:

implanting an adjusting assembly at an intraventricular site of aventricle of a patient;

accessing the adjusting assembly by an extracardiac tool from a siteexternal to a body of the patient by passing the tool through anelongate coupling tube that is coupled at a first end thereof to theintraventricular adjusting assembly and at second end thereof to aportion of subcutaneous tissue of the patient.

There is also provided, in accordance with some applications of thepresent invention, a method including:

advancing a distal end of a central shaft of a delivery tool betweenleaflets of an atrioventricular valve of a patient and into a ventricleof the patient;

while maintaining the distal end of the central shaft in place andwithin the ventricle:

-   -   proximally withdrawing a surrounding shaft of the delivery tool        with respect to the distal end of the central shaft and toward        the leaflets, which surrounding shaft surrounds a portion of the        central shaft; and    -   using the surrounding shaft, engaging at least one of the        leaflets with at least one leaflet-engaging element; and

after engaging, proximally withdrawing the distal end of the centralshaft from within the ventricle.

In some applications of the present invention, advancing the distal endof the central shaft comprises transcatheterally advancing the deliverytool toward the leaflets.

In some applications of the present invention, maintaining the centralshaft in place and within the ventricle includes securing the distal endof the central shaft to tissue of the ventricle.

In some applications of the present invention, engaging the at least oneleaflet includes engaging exactly one leaflet.

There is further provided, in accordance with some applications of thepresent invention, apparatus, including:

at least one leaflet-engaging element;

a catheter; and

a delivery tool, which is advanceable within the catheter, and whichincludes a central shaft and a surrounding shaft that surrounds aportion of the central shaft and is slidable along the central shaft, adistal end of the central shaft configured to be advanced betweenleaflets of an atrioventricular valve of a patient and into a ventricleof the patient,

and the surrounding shaft is configured to engage at least one of theleaflets with the at least one leaflet-engaging element while the distalend of the central shaft is maintained in place and within theventricle.

In some applications of the present invention, the surrounding shaft isconfigured to engage the at least one of the leaflets by sliding withrespect to the distal end of the central shaft.

In some applications of the present invention, the surrounding shaft isconfigured to engage exactly one of the leaflets of the at least oneleaflet-engaging element.

In some applications of the present invention, the distal end of thecentral shaft is configured to be coupled to tissue of the ventricle atan intraventricular site.

There is yet further provided, in accordance with some applications ofthe present invention apparatus including:

a sheath, which is configured to be advanced into an atrium of a patientin a transcatheter procedure;

an implant assembly, which is configured to be passed through thesheath, and which includes:

-   -   at least one leaflet-engaging element;    -   a spool; and    -   at least one artificial chordea tendinea, which has opposite        first and second end portions, which first end portion is        coupled to the spool, and which second end portion is coupled to        the at least one leaflet-engaging element; and

a delivery tool, which is configured to be passed through the sheath,and which includes:

-   -   a central shaft, which is configured to be advanced between        leaflets of an atrioventricular valve of the patient and into a        ventricle of the patient, and which is configured to be        removably coupled to the spool, and to couple the spool at an        intraventricular site of the ventricle;    -   a surrounding shaft, which surrounds a portion of the central        shaft, and is slidable with respect to the central shaft; and    -   a coupling element holder, which is coupled to the surrounding        shaft, and which is configured to couple the at least one        leaflet-engaging element to at least one leaflet of the        atrioventricular valve.

In some applications of the present invention, the at least oneartificial chordea tendinea and the spool are configured such thatrotation of the spool winds the at least one artificial chordea tendineaaround the spool, thereby drawing the at least one leaflet-engagingelement toward the spool.

In some applications of the present invention, the delivery tool furtherincludes a torque-delivering tool, the central shaft is shaped to defineat least one lumen, and the torque-delivering tool is disposed in thelumen and is configured to rotate the spool.

In some applications of the present invention, the delivery tool furtherincludes:

at least one guide wire coupled to the spool; and

a screwdriver housing, which is coupled to the central shaft in avicinity of a distal end thereof, and which is configured to beremovably coupled to the spool and advanceable along the guide wire.

In some applications of the present invention, the at least oneartificial chordea tendinea is configured such that a length thereof isadjustable from a site outside of a body of the patient.

In some applications of the present invention,

the at least one artificial chordea tendinea includes first and secondartificial chordeae tendineae having respective first and second endportions,

the spool is coupled to the first end portions of the first and secondartificial chordeae tendineae,

the at least one leaflet-engaging element includes first and secondleaflet-engaging elements, which are coupled to the second end portionof the first artificial chordea tendinea and the second end portion ofthe second artificial chordea tendinea, respectively, and

the coupling element holder is configured to couple the first and secondleaflet-engaging elements to respective first and second leaflets.

In some applications of the present invention, the central shaft, whilecoupled to the spool, is configured to provide a reference force to thecoupling element holder while the coupling element holder couples the atleast one leaflet-engaging element to the at least one leaflet.

The present invention will be more fully understood from the followingdetailed description of embodiments thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration of respective portions of a deliverytool system for implanting and adjusting repair chords, in accordancewith some applications of the present invention;

FIG. 2 is a schematic illustration of the delivery tool system of FIG.1, in accordance with some applications of the present invention;

FIG. 3 is a schematic illustration of a spool assembly coupled to adistal end of the delivery tool of FIG. 1, in accordance with someapplications of the present invention;

FIGS. 4A-C are schematic illustrations of respective components of anadjusting mechanism of the spool assembly of FIG. 3, in accordance withsome applications of the present invention;

FIGS. 5A-G are schematic illustrations of a procedure for using thedelivery tool to implant the spool assembly at a papillary muscle andadjust the repair chords, in accordance with some applications of thepresent invention;

FIG. 6 is a schematic illustration of a port mechanism being coupled tothe spool assembly, in accordance with some applications of the presentinvention;

FIG. 7 is a schematic illustration of the spool assembly and the repairchords, in accordance with some applications of the present invention;

FIG. 8 is a schematic illustration of the adjusting mechanism beingimplanted at a portion of a ventricular wall, in accordance with someapplications of the present invention;

FIGS. 9A-K are schematic illustrations of a system for implanting andadjusting repair chords, and a transcatheter procedure for implantingthe chords in a heart, in accordance with some applications of thepresent invention;

FIGS. 10A-G are schematic illustrations of another system for implantingand adjusting repair chords, and a transcatheter procedure forimplanting the chords in a heart, in accordance with some applicationsof the present invention;

FIGS. 11A-E are schematic illustrations of yet another system forimplanting and adjusting repair chords, and a transcatheter procedurefor implanting the chords in a heart, in accordance with someapplications of the present invention;

FIGS. 12A-G are schematic illustrations of an additional system forimplanting and adjusting repair chords, and a transcatheter procedurefor implanting the chords in a heart, in accordance with someapplications of the present invention;

FIG. 13 is a schematic illustration of another configuration of thesystem of FIGS. 12A-G, in accordance with some applications of thepresent invention;

FIGS. 14A-E are schematic illustrations of yet an additional system forimplanting and adjusting repair chords, and a transcatheter procedurefor implanting the chords in a heart, in accordance with someapplications of the present invention;

FIGS. 15A-C are schematic illustrations of a non-continuous ring and adeforming rod of the system of FIGS. 14A-E, in accordance with someapplications of the present invention;

FIGS. 16A-B are schematic illustrations of another configuration of thenon-continuous ring of the system of FIGS. 14A-E, in accordance withsome applications of the present invention;

FIGS. 17A-G are schematic illustrations of still another system forimplanting and adjusting repair chords, and a transcatheter procedurefor implanting the chords in a heart, in accordance with someapplications of the present invention;

FIGS. 18A-D are schematic illustrations of yet another system forimplanting and adjusting repair chords, and a transcatheter procedurefor implanting the chords in a heart, in accordance with someapplications of the present invention;

FIGS. 19, 20A-B, and 21 are schematic illustrations of the repair chordsused to draw portions of a ventricular wall toward one another, inaccordance with some applications of the present invention;

FIGS. 22A-C are schematic illustrations of the repair chords used todraw together leaflets of an atrioventricular valve, in accordance withsome applications of the present invention;

FIG. 23 is a schematic illustration of the repair chords used to drawtogether leaflets of the atrioventricular valve, in accordance with someother applications of the present invention; and

FIGS. 24A-I are schematic illustrations of yet another system forimplanting and adjusting repair chords, and a transcatheter procedurefor implanting the chords in a heart, in accordance with someapplications of the present invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is now made to FIGS. 1-2, which are schematic illustrations ofa system 10 comprising apparatus for implanting and adjusting repairchords in a heart of a patient, in accordance with some applications ofthe present invention. FIG. 1 is a schematic illustration of a portionof the respective components of system 10 showing the relationshipbetween the components. System 10 comprises a delivery tool 20 having aproximal handle portion 24 and an elongate multilumen shaft 22. System10 further comprises an implant assembly 16, which comprises a spoolassembly 240 that is reversibly couplable to a distal portion ofdelivery tool 20. Spool assembly 240 comprises an adjusting mechanism 40that is coupled to a tissue anchor 50. Tissue anchor 50 is shown as ahelical anchor by way of illustration and not limitation, and maycomprise staples, clips, spring-loaded anchors, or other tissue anchorsknown in the art. Alternatively, spool assembly 240 does not includetissue anchor 50 and is, instead, sutured or otherwise attached to aportion of tissue of a ventricle wall which faces a ventricular lumen ofa heart of a patient.

Shaft 22 comprises a multilumen shaft defining a primary lumensurrounding a torque-delivering tool 26 which is surrounded by anovertube 90 (as shown in the transverse cross-section of tool 20 in FIG.2). Torque-delivering tool 26 is coupled at a proximal end thereof to arotating structure 32 that is coupled to handle 24 and, in response torotation thereof, functions to deliver torque to torque-delivering tool26. Torque-delivering tool 26 rotates in response to rotation ofrotating structure 32 and delivers torque to adjusting mechanism 40coupled to the distal end of tool 20.

(In this context, in the specification and in the claims, “proximal”means closer to the orifice through which tool 20 is originally placedinto the body of the subject, and “distal” means further from thisorifice.)

FIG. 2 shows delivery tool 20 in its assembled state. Implant assembly16 comprises longitudinal members 60 and 62 which function as the repairchords that are ultimately implanted in the heart of the patient.Respective first end portions of longitudinal members 60 and 62 arecoupled to a spool that is housed within a spool housing 42 of spoolassembly 240. Thus, implant assembly 16 comprises spool assembly 240 andlongitudinal members 60 and 62. Each longitudinal member 60 and 62 has afree end that is coupled to a respective suture needle 64. The pointedtips of each needle 64 are disposed within a respective slit 72 of aneedle holder 70. Each longitudinal member 60 and 62 extends from itsfirst portions thereof, through a respective secondary lumen 192 ofmultilumen shaft 22 (as shown in the transverse cross-section of shaft22) toward needle holder 70. Needle holder 70 is shaped to provide knobs170 for looping portions of each longitudinal member 60 and 62therearound. During delivery of spool assembly 240 to the implantationsite in the ventricle of the patient, portions of longitudinal members60 and 62 are wound around knobs 170 of needle holder 70 and needles 64are disposed within slits 72 of needle holder 70 so as to facilitateatraumatic delivery of spool assembly 240 to the implantation site.During the implantation of longitudinal members 60 and 62 in the heartof the patient, needles 64 are extracted from slits 72, and longitudinalmembers 60 and 62 are unwound from knobs 170. Unwinding longitudinalmembers 60 and 62 extends longitudinal members 60 and 62 and providesthe operating physician with enough slack to suture respective portionsof longitudinal members 60 and 62 to heart tissue (e.g., a valve leafletor a portion of the ventricle wall) that faces and surrounds theventricular lumen of the heart.

It is to be noted that the scope of the present invention includes theuse of only one longitudinal member that is looped through spoolassembly 240 in a manner which defines first and second portions 60 and62 of the longitudinal member which extends from the spool assembly,mutatis mutandis.

Typically, longitudinal members 60 and 62 comprise a flexible and/orsuperelastic material, e.g., ePTFE, nitinol, PTFE, polyester, stainlesssteel, or cobalt chrome. In some applications of the present invention,longitudinal members 60 and 62 are coated with polytetrafluoroethylene(PTFE) or with PTFE. In some applications of the present invention,longitudinal members 60 and 62 comprise at least one wire/suture portionand at least one portion that comprises an elongate tensioning coil. Forexample, longitudinal members 60 and 62 may comprise an elongate coilbetween two wire/suture portions.

For some applications of the present invention, following initialimplantation, the length of longitudinal members 60 and 62 are adjusted(either shortened or lengthened) from a site outside the patient's body.For example, the length may be adjusted by applying RF or ultrasoundenergy to the members.

Shaft 22 defines longitudinal slits 122 that run parallel with respectto a longitudinal axis of tool 20. Once longitudinal members 60 and 62are unwound from knobs 170, they are pulled from within lumens 192, viaslits 122, and away from the longitudinal axis of tool 20 in order torelease longitudinal members 60 and 62 from within shaft 22.

A distal portion of delivery tool 20 comprises a screwdriver housing 28which houses a screwdriver tool, as is described hereinbelow. Housing 28is shaped to define graspers 30 which reversibly grasp housing 42 ofadjusting mechanism 40 of spool assembly 240. Graspers 30 have atendency to compress toward one another (i.e., are biased inwardly), andthus are clamped around housing 42. As shown in the enlarged distalportion of tool 20, longitudinal members 60 and 62 of implant assembly16 emerge from within housing 42. The spool disposed within housing 42is not shown for clarity of illustration; however, it is to be notedthat respective portions of longitudinal members 60 and 62 are coupledto the spool. One or more (e.g., a pair, as shown) of guide wires 160and 162 are (1) coupled at respective first ends thereof to housing 42and extend (2) through respective proximal openings 29 in screwdriverhousing 28, (3) through respective secondary lumens 194 of multilumenshaft 22 (as shown in the transverse cross-section of shaft 22), and (4)are coupled at respective second ends thereof to handle portion 24. Inthese applications, following implantation and adjustment of the repairchords, as described hereinbelow, guide wires 160 and 162 may be cut andpulled away from housing 42. For some applications of the presentinvention, guide wires 160 and 162 are reversibly coupled to housing 42by being looped through a portion of the housing. In these applications,following implantation and adjustment of the repair chords, as describedhereinbelow, guide wires 160 and 162 may be pulled away from housing 42.

FIG. 3 shows a cross-sectional image of a distal portion of tool 20 andspool assembly 240 that is coupled to delivery tool 20 via graspers 30of screwdriver housing 28, in accordance with some applications of thepresent invention. Spool assembly 240 comprises an adjusting mechanism40 that is coupled to, e.g., welded to, a helical tissue anchor 50.Adjusting mechanism 40 comprises a housing 42 which houses a rotatablestructure, or a spool 46. Spool 46 has a cylindrical body that isdisposed in parallel with respect to the longitudinal axis of tool 20 byway of illustration and not limitation. Respective portions 63 oflongitudinal members 60 and 62 are coupled to (e.g., welded to, knottedto, looped within, or otherwise fastened to) spool 46 at coupling sites260 and 262, respectively.

Longitudinal members 60 and 62 extend externally to screwdriver housing28 and through respective secondary lumens 192 of multilumen shaft 22.It is to be noted that although two longitudinal members 60 and 62 areshown as being coupled to spool 46, any suitable number of longitudinalmembers may be coupled to spool 46. In some applications of the presentinvention, only one longitudinal member is coupled at a first endthereof to spool 46, and the second end of the longitudinal member isconfigured to be attached to heart tissue, e.g., a leaflet of anatrioventricular valve or a portion of the ventricular wall. In someapplications of the present invention, the atrioventricular valveincludes a mitral valve of the patient. In some applications of thepresent invention, the atrioventricular valve includes a tricuspid valveof the patient. For some applications of the present invention, the onelongitudinal member may be looped within spool 46 in a manner in which amiddle portion thereof is looped within the spool and respectiveportions thereof extend from spool 46 along shaft 22 in their respectivelumens 192. In such some applications of the present invention, the onelongitudinal member defines two free ends which are coupled to sutureneedles and are ultimately attached to, e.g., sutured to, heart tissue.For applications in which spool assembly 240 is advanced to the heartduring a transcatheter procedure, the free ends of longitudinal members60 and 62 are coupled to tissue-engaging elements which engage the hearttissue without suturing, as is described hereinbelow.

A distal end of shaft 22 is disposed proximally to a proximal end ofscrewdriver housing 28. As described hereinabove, torque-delivering tool26 and overtube 90 that surrounds torque-delivering tool 26 are disposedwithin primary lumen 190 of shaft 22. Screwdriver housing 28 is shapedto define a primary lumen which receives a distal portion oftorque-delivering tool 26 and a distal portion of overtube 90. Duringdelivery of spool assembly 240 to the implantation site in theventricle, a distal end of overtube 90 is disposed within housing 28proximally to a distal end of torque-delivering tool 26. A distalportion of torque-delivering tool 26 is disposed within a screwdriverhead 95 that is disposed within housing 28. Screwdriver head 95 defineda recess for receiving and coupling the distal portion oftorque-delivering tool 26. Screwdriver head 95 is shaped to provide aspool-rotating portion 94 which fits within a channel defined by spool46. Spool-rotating portion 94 is shaped in accordance with the shape ofthe channel defined by spool 46 such that rotation of torque-deliveringtool 26 delivers torque to and rotates screwdriver head 95. In responseto the rotation of screwdriver head 95, spool-rotating portion 94 pushesagainst the wall of spool 46 that defines the channel extendingtherethrough, and responsively, spool 46 is rotated.

Reference is now made to both FIGS. 2 and 3. As shown in FIG. 2, guidewires 160 and 162 extend from spool housing 42 and through openings 29defined in screwdriver housing 28. Since guide wires 160 and 162 aredisposed within lumens of multilumen shaft 22 that are orthogonal withrespect to lumens 192 (which surround longitudinal members 60 and 62),guide wires 160 and 162 are not shown in FIG. 3. Similarly, the openings29 of screwdriver housing 28 are not shown in FIG. 3. It is to be notedthat screwdriver housing is shaped to define a respective secondarylumen which surrounds each guide wire 160 and 162 and extend from spoolhousing 42 toward each proximal opening 29 in screwdriver housing 28.These secondary lumens run in parallel with respect to the primary lumendefined by housing 28 that surrounds torque-delivering tool 26 andovertube 90.

FIG. 4A shows a relationship among individual components of adjustingmechanism 40, in accordance with some applications of the presentinvention. Adjusting mechanism 40 is shown as comprising spool housing42 which defines an upper surface 41 and a recessed portion 142. Spool46 is configured to be disposed within housing 42 and defines an uppersurface 150, a lower surface 152 and a cylindrical body portion disposedvertically between surfaces 150 and 152. Spool 46 is shaped to provide adriving interface, e.g., a channel 48, which extends from an openingprovided by upper surface 150 to an opening provided by lower surface152. Channel 48 of the driving interface is shaped to define a hexagonalchannel or a channel having another shape. The cylindrical body portionof spool 46 is shaped to define holes, or coupling sites 260 and 262which function as respective coupling sites for coupling longitudinalmembers 60 and 62 to spool 46. In some applications of the presentinvention, system 10 described herein comprises only one longitudinalmember which is looped through spool 46 via coupling sites 260 and 262.

Coupling sites 260 and 262 may be shaped to define holes, as shown, orslits through which respective portions of longitudinal members 60 and62 are looped therethrough. In some applications of the presentinvention, respective portions of longitudinal members 60 and 62 arelooped through coupling sites 260 and 262 such that their ends aredisposed within channel 48 of spool 46. The ends of longitudinal members60 and 62 are knotted within channel 48 so as to fix the ends withinchannel 48 and prevent their release from spool 46. In some applicationsof the present invention, coupling sites 260 and 262 are shaped todefine male projections, e.g., knobs or hooks, around which respectiveportions of longitudinal members 60 and 62 are ensnared or looped andthereby coupled to spool 46.

Lower surface 152 of spool 46 is shaped to define one or more (e.g., aplurality, as shown) recesses 154 which define structural barrierportions 155 of lower surface 152. It is to be noted that any suitablenumber of recesses 154 may be provided, e.g., between 1 and 10 recesses,circumferentially with respect to lower surface 152 of spool 46.

A locking mechanism 45 is coupled to lower surface 152 and is coupled,e.g., welded, at least in part to a lower surface of spool housing 42.Typically, locking mechanism 45 defines a mechanical element having aplanar surface that defines slits 58. It is to be noted that the surfaceof locking mechanism 45 may also be curved, and not planar. Lockingmechanism 45 is shaped to provide a protrusion 156 which projects out ofa plane defined by the planar surface of the mechanical element. Slits58 define a depressible portion 128 of locking mechanism 45 that isdisposed in communication with and extends toward protrusion 156.Depressible portion 128 is in communication with the opening at lowersurface 152 of spool 46 and is moveable in response to a force appliedthereto typically by screwdriver head 95, as shown in detail hereinbelowwith reference to FIGS. 4B-C.

It is to be noted that the planar, mechanical element of lockingmechanism 45 is shown by way of illustration and not limitation and thatany suitable mechanical element having or lacking a planar surface butshaped to define at least one protrusion may be used together withlocking mechanism 45.

A cap 44 is provided that is shaped to define a planar surface and anannular wall having an upper surface 244 thereof. Upper surface 244 ofthe annular wall is coupled to, e.g., welded to, a lower surfaceprovided by spool housing 42. The annular wall of cap 44 is shaped todefine a recessed portion 144 of cap 44 that is in alignment withrecessed portion 142 of spool housing 42.

Reference is now made to FIGS. 4B-C, which are schematic illustrationsof adjusting mechanism 40 in respective locking states thereof, inaccordance with some applications of the present invention. It is to benoted that longitudinal members 60 and 62 that are typically coupled tospool 46, are not shown for clarity of illustration. FIG. 4B showsadjusting mechanism 40 in an unlocked configuration in which protrusion156 of locking mechanism 45 is disposed within recessed portion 144 ofcap 44. FIG. 4C shows the locked state of spool 46 by the positioning ofprotrusion 156 within a recess 154 of spool 46.

Reference is again made to FIGS. 3 and 4B-C. FIG. 4B shows adjustingmechanism 40 in an unlocked state thereof, as shown in FIG. 3. During(1) the delivery of spool assembly 240 to the implantation site in afirst portion of tissue defining the ventricular lumen of the patient,(2) the attachment of the longitudinal members to a second portion ofheart tissue that faces surrounds the ventricular lumen of the patient,and (3) the subsequent rotation of spool 46 to adjust a length oflongitudinal members 60 and 62 between the first and second portions ofheart tissue (and consequently, a distance between the first and secondportions of heart tissue), adjusting mechanism 40 is disposed in anunlocked state, as shown in FIGS. 3 and 4B. As shown in FIG. 4C, spool46 is shaped to provide a first opening 180 at upper surface 150 thereofand a second opening 182 at a lower surface 152 thereof. Spool 46defines a channel 48 that extends from first opening 180 toward secondopening 182.

FIGS. 3 and 4B show adjusting mechanism 40 in an unlocked state thereofin which screwdriver head 95 is disposed within channel 48 of spool 46.Screwdriver head 95 comprises an elongate body shaped to define aproximal generally cylindrical structure and spool-rotating portion 94which fits within channel 48 defined by spool 46. Spool-rotating portion94 is shaped to define a distal force applicator 93 which is disposedproximally to and in communication with depressible portion 128 oflocking mechanism 45. In the unlocked state of adjusting mechanism 40,screwdriver head 95 is disposed with respect to housing 42 in a mannerin which a distal end of force applicator 93 extends beyond secondopening 182 of spool 46 and pushes against depressible portion 128 oflocking mechanism 45. Depressible portion 128 is thus pushed downward,as shown.

Channel 48 of spool 46 is shaped to accommodate the dimensions ofspool-rotating portion 94 and force applicator 93 of screwdriver head95. Spool-rotating portion 94 has a width that is wider than the forceapplicator 93. In turn, channel 48 of spool 46 is shaped to accommodatespool-rotating portion 94 and force applicator 93 defining an upperportion and a lower portion thereof in which the upper portion ofchannel 48 is wider than the lower portion. The narrower lower portionof channel 48 ensures that force applicator 93 is not advanced distallybeyond a certain point as the narrower lower portion of channel 48restricts passage therethrough of the upper, wider portion ofspool-rotating portion 94. Screwdriver head 95 is shaped to define ashelf portion 91 which rests against upper surface 41 of spool housing42. Similarly, spool-rotating portion 94 is shaped to define a shelfportion 143 which rests against a horizontal wall of spool 46 whichdefines a portion of channel 48. During the unlocked state of adjustingmechanism 40, screwdriver head 95 is disposed in a manner in which shelfportion 91 thereof rests against upper surface 41 of spool housing 42,and shelf portion 143 of spool-rotating portion 94 rests against thehorizontal wall of channel 48, as shown.

For some applications of the present invention, spool-rotating portion94 is threaded, and a portion of spool 46 that defines channel 48 isthreaded to accommodate the threaded portion of spool-rotating portion94. In such an application, the threaded portions of spool-rotatingportion 94 and of spool 46 facilitate rotation of spool 46.

During the unlocked state of adjusting mechanism 40, depressible portion128 is maintained in a pushed state by force applicator 93. In such astate, protrusion 156 of locking mechanism 45 is maintained in a pushedstate toward the planar surface of cap 44. It is to be noted that thesurface of cap 44 may also be curved, and not planar. As describedhereinabove, cap 44 is shaped to provide a recessed portion 144 forreceiving protrusion 156 in its pushed-down state. As depressibleportion 128 is pushed downward, protrusion 156 is freed from within arecess 154 defined by structural barrier portions 155 of the lowerportion of spool 46. Additionally, protrusion 156 is freed from withinrecessed portion 142 provided by spool housing 42. Responsively,adjusting mechanism 40 is unlocked, and spool 46 may be rotated byscrewdriver head 95 in either clockwise or counter-clockwise directionsin response to torque delivered to head 95 by torque-delivering tool 26coupled thereto. In response to the torque, spool-rotating portion 94 ofscrewdriver head 95 engages and pushes against the wall defining channel48 in order to rotate spool 46.

Cap 44 functions to restrict distal pushing of depressible portion 128beyond a desired distance so as to inhibit deformation of lockingmechanism 45. Once adjustment mechanism 40 is implanted in heart tissue,cap 44 also provides an interface between adjusting mechanism 40 and theheart tissue. This prevents interference of heart tissue on adjustingmechanism 40 during the locking and unlocking thereof. Additionally, cap44 prevents damage to heart tissue by depressible portion 128 as it ispushed downward.

FIG. 4C shows adjusting mechanism 40 in a locked state thereof in whichlocking mechanism 45 is shown in a resting state thereof. In the restingstate of locking mechanism 45, depressible portion 128 is disposed in ahorizontal position (i.e., perpendicularly with respect to alongitudinal axis of channel 48) in response to removal of screwdriverhead 95 from within channel 48 of spool 46. Depressible portion 128 hasa tendency to assume the horizontal position, as shown, and in theabsence of a downward pushing force applied to depressible portion 128by screwdriver head 95, depressible portion 128 returns to itshorizontal position from its pushed-down state, as shown in FIG. 4B. Inthis horizontal position, protrusion 156 of locking mechanism 45 isremoved from recessed portion 144 of cap 44 and is returned within arecess 154 of spool 46 and thereby restricts movement of spool 46 andlocks adjusting mechanism 40. Additionally, protrusion 156 of lockingmechanism 45 returns in part within recessed portion 142 of spoolhousing 42. Thus, recessed portion 142 of spool housing 42 providessupplemental locking of locking mechanism 45.

Reference is now made to FIGS. 5A-G, which are schematic illustrationsof a method for implantation of spool assembly 240 and longitudinalmembers 60 and 62 of system 10 in the heart of the patient, inaccordance with some applications of the present invention. FIG. 5Ashows an open heart procedure in which an operating physicianpositioning tool 20 in a heart 2 of a patient and implanting spoolassembly 240 in tissue of a papillary muscle 4 of the left ventricle ofheart 2. FIG. 5A shows the general relative perspective of tool 20 withrespect to heart 2. It is to be noted that FIGS. 5A-G are not drawn toscale in order to illustrate clearly the function of tool 20 in heart 2.

FIG. 5B shows a distal portion of tool 20 disposed within the leftventricle of heart 2. The operating physician advances a distal portion71 of tool 20 between leaflets 12 and 14 of a mitral valve 8. Tool 20 isdisposed with respect to heart 2 in a manner in which needle holder 70is disposed outside of heart 2. As shown in the enlarged portion ofneedle holder 70, needle 64 of longitudinal member 60 is disposed withinslit 72 of needle holder 70. Additionally, longitudinal member 60 islooped around knobs 170 of needle holder 70 such that knobs 170 gatherexcess portions of longitudinal member 60. Longitudinal member 60emerges from within slit 122 defined by multilumen shaft 22 at aproximal opening 61 of slit 122. Longitudinal member 62 is also shown asemerging from within its respective slit in shaft 22. The needle coupledto longitudinal member 62 is also housed within a slit provided byneedle holder 70 (needle not shown for clarity of illustration).

Delivery tool 20 is rotated in order to screw helical anchor 50 of spoolassembly 240 into tissue of papillary muscle 4 at an intraventricularimplantation site 5. Spool assembly 240 is coupled to cardiac tissue ina manner in which spool housing 42 and spool 46 are disposed within theventricular lumen at the intraventricular implantation site. Tissueanchor 50 is screwed into the cardiac tissue in a manner in which it isdisposed fully within the heart tissue, e.g., papillary muscle,endocardium, or myocardium, and does not extend beyond a pericardium ofthe heart. Papillary muscle 4 includes a portion of cardiac tissue whichfaces and surrounds the left ventricular lumen of heart 2. In responseto rotation of tool 20, spool assembly 240 is implanted at a firstimplantation site 5. In the enlarged view of the distal portion of tool20 and spool assembly 240, longitudinal members 60 and 62 (coupled tospool 46) and guide wires 160 and 162 (coupled to housing 42) are shownas emerging from housing 42 and are fed within their secondaryrespective lumens of multilumen shaft 22.

Guide wires 160 and 162 extend within their respective lumens 194 ofshaft 22 and toward handle 24. Handle 24 is shaped to provide a handlelumen 23 thereof, as shown in the enlarged longitudinal cross-sectionalimage of handle 24 (section A-A). A guide wire grasper 250 is disposedwithin lumen 23 and is coupled to the proximal ends of each guide wire160 and 162. Handle lumen 23 has a handle-lumen-length L1 of between 50mm and 100 mm, e.g., 70 mm. A proximal end 25 of multilumen shaft 22 isdisposed at a distal portion of lumen 23.

A proximal portion 241 of multilumen shaft 22 (i.e., the portion ofshaft 22 that is disposed immediately distal to proximal end 25 of shaft22) is configured to slide within lumen 23. Proximal portion 241 ofshaft 22 slides within lumen 23 when the operating physician graspsshaft 22 and slides shaft 22 proximally. Proximal portion 241 of shaft22 also has a shaft-length L2 such that proximal portion 241 fits withinhandle lumen 23, as is described hereinbelow. A guide 27 is coupled toproximal end 25 of shaft 22 and is advanced proximally within lumen 23in response to proximal sliding of portion 241 of shaft 22 within lumen23. Ultimately, in response to the sliding of proximal portion 241 ofshaft 22 within lumen 23 of handle 24, distal portion 71 of shaft 22slides proximally with respect to overtube 90 such that distal portion71 is disposed entirely within the left atrium of the patient, i.e., notwithin the left ventricle (as shown in FIG. 5D).

As shown, following the proximal sliding of shaft 22, needle holder 70is positioned proximally and adjacently to the distal end of handle 24.

Section B-B shows a transverse cross-section of delivery tool 20 at adistal portion of handle 24. Section B-B shows handle 24 which surroundsguide 27. Guide 27, in turn, surrounds a proximal end of multilumenshaft 22. Torque-delivering tool 26 surrounded by overtube 90 aredisposed within the primary lumen of shaft 22. As shown, guide wires 160and 162 are disposed within secondary lumens 194 of shaft 22. Secondarylumens 192 (which house longitudinal members 60 and 62 at the portion oftool between needle holder 70 and the distal end of shaft 22) are emptyat handle 24 because longitudinal members 60 and 62 exit lumens 192distally to needle holder 70.

As shown in Section A-A, handle 24 comprises a torque facilitator (e.g.,a spring) 132 that is coupled to and surrounds a proximal portion oftorque-delivering tool 26. Torque-delivering tool 26 (surrounded byovertube 90) extends proximally within handle 24 and is coupled torotating structure 32 at the proximal end of handle 24.

FIG. 5C shows the extracting of longitudinal members 60 and 62 fromwithin their respective lumens 192 of shaft 22. Needles 64 are pulledfrom within slits 72 of needle holder 70. Then, longitudinal members 60and 62 are unwound from knobs 170 of needle holder 70 and pulled awayfrom the longitudinal axis of shaft 22 along slits 122 of shaft 22.Following the extracting of longitudinal members 60 and 62 from theirrespective lumens 192, needles 64 are held outside heart 2 so as not topuncture tissue of the heart. The free ends of longitudinal members 60and 62, which are coupled to needles 64 are then sutured to leaflet 12at a second implantation site 7 at a portion of heart tissue which facesand surrounds the ventricular lumen of heart 2.

FIG. 5D shows longitudinal members 60 and 62 coupled to leaflet 12 atsecond implantation site 7. Longitudinal members 60 and 62 are knottedtogether using suture knots 67, and excess portions of longitudinalmembers 60 and 62 are cut away from knot 67. It is to be noted thatalthough knot 67 is used to couple longitudinal members 60 and 62 toleaflet 12, any suitable anchor may be used, or any tissue-engagingelement, as described hereinbelow. For example, longitudinal member 60may comprise a male clip at its free end and longitudinal member 62 maycomprise a female clip at its free end. In such some applications of thepresent invention, longitudinal members 60 and 62 are clipped at theirfree ends to leaflet 12.

Following the coupling of longitudinal members 60 and 62 to leaflet 12,shaft 22 is slid proximally by the operating physician to expose aportion of overtube 90 and torque-delivering tool 26. During theproximal sliding of shaft 22, proximal portion 241 of shaft 22 is slidwithin lumen 23 of handle 24. Handle-lumen-length L1 of lumen 23 ofhandle 24 is long enough to accommodate shaft-length L2 of proximalportion 241 of shaft 22. In response to the sliding of shaft 22, thedistal portion of the exposed overtube 90 and torque-delivering tool 26defines a torque-delivering tool length L3 at a distal portion thereofthat is equal to shaft-length L2 of proximal portion 241 of shaft 22.Thus, handle-lumen-length L1, shaft-length L2 at proximal portion 241 ofshaft 22, and torque-delivering tool length L3 at the distal portionthereof are generally equal and have a ratio of between 0.7:1 and 1.3:1.

Shaft-length L2 of proximal portion 241 of shaft 22 is such that whenportion 241 slides within lumen 23 of handle 24 as shaft 22 is slidproximally along overtube 90, a distal-most end 65 of shaft 22 isdisposed proximally to mitral valve 8 (i.e. distal-most end 65 of shaft22 is disposed in the left atrium of heart 2). Typically, multilumenshaft 22 has a diameter of between 1.5 mm and 4 mm, typically, 3 mm, andovertube 90 (i.e., the portion of tool 20 that is configured to bedisposed between the leaflets of the valve) has a diameter of between0.8 mm and 1.5 mm, typically, 1.5 mm. Sliding of shaft 22 to positiondistal-most end 65 of shaft 22 in the left atrium, thus reduces thediameter of tool 20 between leaflets 12 and 14 of valve 8.

Following the sliding, the incision is closed around tool 20 using apurse string stitch, for example. The patient is removed from thecardiopulmonary bypass pump and heart 2 is allowed to resume its normalfunction. While heart 2 is beating, spool 46 of adjustment mechanism 40may then be rotated in order to adjust a length of longitudinal members60 and 62, and responsively, a distance between first and secondimplantation sites 5 and 7 is adjusted (and a length of longitudinalmembers 60 and 62 is adjusted). The adjustment of longitudinal membersis typically performed with the aid of imaging, such as fluoroscopy,transesophageal echo, and/or echocardiography.

Sliding of shaft 22 thus reduces the diameter of the portion of tool 20that is disposed between leaflets 12 and 14, and thus, reducesinterference of tool 20 on the beating of valve 8 as longitudinalmembers 60 and 62 are adjusted.

Reference is now made to FIGS. 3 and 5E. FIG. 5E shows the adjustment oflongitudinal members 60 and 62 by adjusting mechanism 40 and deliverytool 20. During the adjustment of longitudinal members 60 and 62,locking mechanism 45 of adjustment mechanism 40 is disposed in anunlocked state with respect to spool 46 (as shown in FIG. 3). Rotatingstructure 32 is rotated in a first direction thereof, as indicated byarrow A. In response to the rotation of structure 32, torque-deliveringtool 26 is rotated. Responsively, screwdriver head 95 that is coupled tothe distal end of torque-delivering tool 26 is rotated andspool-rotating portion 94 pushes against the wall defining channel 48 ofspool 46. Such pushing applies an annular force to the spool whichfacilitates rotation of spool 46 in a first direction thereof.

In response to the rotation of spool 46 in the first direction, asindicated by arrow A, respective first portions of longitudinal members60 and 62 are wrapped around spool 46, as shown in the enlargedcross-sectional image of adjusting mechanism 40. As longitudinal members60 and 62 are wrapped around spool 46, respective second portions ofmembers 60 and 62 (i.e., the portions which are coupled to secondimplantation site 7) are pulled toward adjusting mechanism 40 implantedat first implantation site 5. This draws the second portions oflongitudinal member 60 and 62 and leaflet 12 toward the first portionsof longitudinal members 60 and 62 that are wrapped around spool 46.Responsively, the respective lengths of longitudinal members 60 and 62between the second portions thereof and spool 46 are shortened andlongitudinal members 60 and 62 are tightened.

Since spool 46 is unlocked (as shown in FIG. 3), spool 46 may be rotatedin a second direction that is opposite the direction used to tightenlongitudinal members 60 and 62 (i.e., in the direction that is oppositethat which is indicated by arrow A in FIG. 5E). Rotating spool 46 in thesecond direction unwinds longitudinal members 60 and 62 from aroundspool 46 and thereby elongates the portions of longitudinal members 60and 62 between first and second implantation sites 5 and 7.

Overtube 90 comprises a tube which surrounds torque-delivering tool 26.Since shaft 22 is retracted proximally (as shown) during the adjustmentof longitudinal members 60 and 62, overtube 90 functions to providerigidity and stability to torque-delivering tool 26 as it deliverstorque to spool 46. Overtube 90 comprises a flexible material, e.g.,polyamide, ePTFE, or PTFE. In some applications of the presentinvention, the material of overtube 90 is braided. For some applicationsof the present invention, overtube 90 is coated with PTFE.

As shown in FIG. 5E, longitudinal members 60 and 62 are pulled tightfrom their relaxed state (shown in FIG. 5D) in response to rotationfacilitated by adjusting mechanism 40. Longitudinal members 60 and 62are pulled until they resemble native chordeae tendineae 6, and thuslongitudinal members 60 and 62 function to replace the defective andstretched native chordeae tendineae and restore normal functionality toheart valve 8.

Reference is again made to FIGS. 3 and 5E. FIG. 3 shows screwdriver head95 being shaped to provide a horizontal shelf portion 91 which restsagainst upper surface 41 of spool housing 42. Similarly, spool-rotatingportion 94 is shaped to define a shelf portion 143 which rests against ahorizontal wall of spool 46 which defines a portion of channel 48.During the unlocked state of adjusting mechanism 40 (as shown in FIG.3), screwdriver head 95 is disposed in a manner in which shelf portion91 thereof rests against upper surface 41 of spool housing 42, and shelfportion 143 of spool-rotating portion 94 rests against the horizontalwall of channel 48, as shown.

Following the adjustment of the respective lengths of longitudinalmembers 60 and 62, delivery tool 20 is decoupled from spool assembly240. The operating physician pushes on rotating structure 32, in thedirection as indicated by arrow B in FIG. 5E. The proximal portion ofhandle 24 is shaped to define a recessed portion for receiving a distalportion of rotating structure 32 in response to the pushing thereof.Pushing on rotating structure 32 thereby pushes torque-delivering tool26 coupled thereto. Responsively, screwdriver head 95 that is coupled totorque-delivering tool 26 is pushed distally. As screwdriver head 95 ispushed, shelf portion 91 pushes against upper surface 41 of housing 42in order to facilitate pulling of tool 20 away from spool assembly 240.Responsively, screwdriver head 95 and graspers 30 are distanced fromhousing 42, as shown in the enlarged cross-sectional image of adjustmentmechanism 40.

Graspers 30 are resiliently biased to angle inward and surround thecurved outer wall of housing 42. Following the pushing of shelf portion91 of screwdriver head 95 against upper surface 41 of housing 42, tool20 is pulled proximally in the direction as indicated by arrow C in theenlarged image of spool assembly 240 and the distal portion of tool 20.During the pulling proximally of tool 20, the curved wall of housing 42pushes against resilient graspers 30 in order to radially push graspers30. Such pushing radially of graspers 30 helps further decouple tool 20from spool assembly 240.

During the decoupling of tool 20 from spool assembly 240, spool-rotatingportion 94 and distal force applicator 93 of screwdriver head 95 arepulled proximally such that the distal end of force applicator 93 isdisposed proximally to and does not apply a pushing force to depressibleportion 128 of locking mechanism 45. In the absence of the downwardpushing force by screwdriver head 95, depressible portion 128 returns toits resting state, i.e., perpendicular with respect to the longitudinalaxis of channel 48. As depressible portion 128 returns to its restingstate, protrusion 156 is introduced within one of the plurality ofrecesses 154 of lower surface 152 of spool 46 and thereby locks andrestricts rotation of spool 46.

FIG. 5F shows delivery tool 20 being pulled away from heart 2 andultimately outside of the body of the patient. Delivery tool 20 slidesalong guide wires 160 and 162 which pass through openings 29 inscrewdriver housing 28 of tool 20. Guide wires 160 and 162 are leftpartially within heart 2 and provide an access to implantation site 5.Sliding of tool 20 along guide wires 160 and 162 frees heart 2 of anytool.

Once free of tool 20, the operating physician may then repair any otherdefect in the heart without any obstruction and interference by tool 20.In some cases, the operating physician introduces a second spoolassembly 240 into another implantation site in the left ventricle andrepairs another portion of heart 2. In some applications of the presentinvention, the second spool assembly is implanted in a second papillarymuscle of the ventricle and the longitudinal member(s) coupled theretoare coupled at their free ends to either leaflet 12 or 14. Thelongitudinal member(s) then function as secondary artificial chordea(e)tendinea(e).

In some applications of the present invention, the second spool assembly240 is coupled to a first portion of the ventricle wall (i.e., and notto the papillary muscle) at the base of the papillary muscle, or atanother portion of the ventricle wall which faces and surrounds theventricular lumen of heart 2 (e.g., a portion of an inner wall of thefree wall of the ventricle, or a portion of the septum of theventricle). In some applications of the present invention, the free endsof the longitudinal member(s) coupled to the second spool assembly arecoupled to either leaflet 12 or 14 (as shown hereinbelow with referenceto FIG. 8). Alternatively, the free ends of the longitudinal member(s)are coupled to a second portion of the ventricle wall (as shownhereinbelow with reference to FIGS. 20A-B) in order to draw the firstand second portions the ventricle wall toward one another.

In either application of the present invention, guide wires 160 and 162remain coupled to housing 42 during and following the initial procedureincluding the implantation of spool assembly and adjustment oflongitudinal members 60 and 62. Guide wires 160 and 162 enable theoperating physician to access implantation site 5 at any time during andafter the initial procedure. During the initial implantation proceduredelivery tool 20 may remain coupled to guide wires 160 and 162 and slidein and out of heart 2. The physician is able to slide tool 20 towardspool assembly 240 and facilitate supplemental rotation of spool 46 andadjustment of longitudinal members 60 and 62. Following the adjustment,tool 20 is slid out of heart 2 and is decoupled from guide wires 160 and162.

FIG. 5G shows a multilumen guide tube 300 coupled at a distal endthereof to spool assembly 240. Guide tube 300 defines a primary lumen302 and respective secondary lumens 304 which surround guide wires 160and 162. Following the removal of tool 20, guide tube 300 is advancedtoward implantation site 5 along guide wires 160 and 162. Guide tube 300is advanced along guide wires 160 and 162 through an opening 330 inheart 2, and ultimately toward implantation site 5. A distal end ofguide tube 300 is coupled to spool housing 42 of spool assembly 240, anda proximal end of guide tube 300 is coupled to a portion of subcutaneoustissue of the patient. A port 320 is coupled to a proximal end of guidetube 300 and is implanted subcutaneously beneath skin 310 of the patienttypically in the vicinity of the ribcage. Port 320 projects slightlyunder skin 310 to create a bump 312.

FIG. 6 is a schematic illustration of extracardiac apparatus comprisingtorque-delivering tool 26 accessing spool assembly 240 via port 320, inaccordance with some applications of the present invention. Thephysician feels for bump 312 of skin 310 and creates a small incision inthe tissue in order to access port 320. Torque-delivering tool 26 isadvanced through primary lumen 302 of guide tube 300 (as shown in thetransverse cross-sectional image of guide tube 300) and accessesadjusting mechanism 40 of spool assembly 240 from a site outside thebody of the patient.

The operating physician may access spool assembly 240 via port 320, at alater stage following initial implantation of assembly 240 in order toreadjust longitudinal members 60 and 62. For example, in the event thatlongitudinal members 60 and 62 are loosened (as shown) and need to betightened, spool assembly 240 may be accessed in order to tightenlongitudinal members 60 and 62.

Torque-delivering tool 26 is coupled at a distal end thereof toscrewdriver head 95. Screwdriver head 95 accesses spool 46 of adjustmentmechanism 40 and rotates spool 46 (in a manner as described hereinabove)in order to adjust longitudinal members 60 and 62. The readjustmentprocedure is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

Reference is now made to FIG. 7, which is a schematic illustration of asystem 400 for implanting spool assembly 240 and adjusting longitudinalmembers 60 and 62, as described hereinabove with reference to FIGS.5A-G, with the exception that guide wires 160 and 162 do not remainpartially disposed within heart 2, in accordance with some applicationsof the present invention. In this application of the present invention,guide wires 160 and 162 are used only during the initial implantation ofspool assembly 240 and adjustment of longitudinal members 60 and 62.Guide wires 160 and 162 in this application of the present invention,facilitate the removal of tool 20 from heart 2 and the replacement oftool 20 in heart 2 during the initial procedure.

FIG. 8 is a schematic illustration of a system 500 for implanting spoolassembly 240 and adjusting longitudinal members 60 and 62, as describedhereinabove with reference to FIGS. 5A-G, with the exception that spoolassembly is implanted in a portion 200 of the heart wall of theventricle, in accordance with some applications of the presentinvention. Portion 200 of the heart wall includes a portion of the wallwhich faces and surrounds the ventricular lumen of heart 2. As shown,the portion of the wall includes a portion of the wall at the apex ofthe heart. It is to be noted that the scope of the present inventionincludes other portions of the wall, e.g., a portion of a free wall ofthe heart, a portion of the septum, or a portion of the wall at the baseof the papillary muscle.

Tissue anchor 50 is screwed into the cardiac tissue in a manner in whichit is disposed fully within portion 200 of the heart tissue, e.g.,endocardium or myocardium, and does not extend beyond a pericardium 202of heart 2.

Reference is now made to FIGS. 9A-K, which are schematic illustrationsof a system for implanting and adjusting repair chords, and atranscatheter procedure for implanting the chords in a heart, inaccordance with some applications of the present invention. Theprocedure is typically performed with the aid of imaging, such asfluoroscopy, transesophageal echo, and/or echocardiography.

The procedure typically begins with the advancing of a semi-rigid guidewire 1024 into a right atrium 1026 of the patient, as shown in FIG. 9A.

As shown in FIG. 9B, guide wire 1024 provides a guide for the subsequentadvancement of a sheath 1028 therealong and into right atrium 1026. Oncesheath 1028 has entered the right atrium, guide wire 1024 is retractedfrom the patient's body. Sheath 1028 typically comprises a 14-20 Fsheath, although the size may be selected as appropriate for a givenpatient. Sheath 1028 is advanced through vasculature into the rightatrium using a suitable point of origin typically determined for a givenpatient. For example:

-   -   sheath 1028 may be introduced into the femoral vein of the        patient, through an inferior vena cava 1030, into right atrium        1026, and into the left atrium transseptally, typically through        the fossa ovalis;    -   sheath 1028 may be introduced into the basilic vein, through the        subclavian vein to the superior vena cava, into right atrium        1026, and into the left atrium transseptally, typically through        the fossa ovalis; or    -   sheath 1028 may be introduced into the external jugular vein,        through the subclavian vein to the superior vena cava, into        right atrium 1026, and into the left atrium transseptally,        typically through the fossa ovalis.

In some applications of the present invention, sheath 1028 is advancedthrough inferior vena cava 1030 of the patient (as shown) and into rightatrium 1026 using a suitable point of origin typically determined for agiven patient.

Sheath 1028 is advanced distally until the sheath reaches theinteratrial septum.

As shown in FIG. 9D, a resilient needle 1032 and a dilator (not shown)are advanced through sheath 1028 and into the heart. In order to advancesheath 1028 transseptally into the left atrium, the dilator is advancedto the septum, and needle 1032 is pushed from within the dilator and isallowed to puncture the septum to create an opening that facilitatespassage of the dilator and subsequently sheath 1028 therethrough andinto the left atrium. The dilator is passed through the hole in theseptum created by the needle. Typically, the dilator is shaped to definea hollow shaft for passage along needle 1032, and the hollow shaft isshaped to define a tapered distal end. This tapered distal end is firstadvanced through the hole created by needle 1032. The hole is enlargedwhen the gradually increasing diameter of the distal end of the dilatoris pushed through the hole in the septum.

The advancement of sheath 1028 through the septum and into the leftatrium is followed by the extraction of the dilator and needle 1032 fromwithin sheath 1028, as shown in FIG. 9E.

As shown in FIG. 9F, the system comprises a delivery tool 1020 and animplant assembly 1016. Delivery tool 1020 comprises a surrounding shaft1022, which is configured to be slidable over and along a central shaft,i.e., overtube 90, such that the surrounding shaft surrounds a portionof the central shaft. Surrounding shaft 1022 typically comprises acoupling element holder 1070, which is fixed to surrounding shaft 1022in a vicinity of the distal end of shaft 1022. A distal portion ofdelivery tool 1020 comprises screwdriver housing 28, as describedhereinabove. The delivery tool further comprises an advancement tube1034, which is configured to hold the other elements of the deliverytool as the delivery tool is advanced through sheath 1028.

Other than as described hereinbelow, implant assembly 1016 is generallysimilar to implant assembly 16, described hereinabove with reference toFIGS. 1-8. Among other features, implant assembly 1016 comprises spoolassembly 240 and longitudinal members 60 and 62. Instead of sutureneedles 64 of implant assembly 16, implant assembly 1016 comprises oneor more leaflet-engaging elements, such as surgical hooks 164, which arecoupled to respective proximal ends of longitudinal member 60 and 62,and are disposed with respective slits 1072 of coupling element holder1070. Optionally, each of the hooks comprises a respective pledget 167,which may help facilitate tissue growth between the hooks and theleaflet. Pledgets 167 may also function to prevent tearing of theleaflets. Alternative leaflet-engaging elements are describedhereinbelow with reference to FIGS. 10A-G, 11A-E, 12A-G, 14A-E, 15A-C,16A-B, 17A-G, 18A-D, and 23A-I.

As shown in FIG. 9F, delivery tool 1020 and implant assembly 1016 areadvanced through sheath 1028 into the left ventricle. All or a portionof the delivery tool is rotated (e.g., central shaft 90) in order toscrew the helical anchor of spool assembly 240 into tissue of papillarymuscle 4.

As shown in FIG. 9G, surrounding shaft 1022 and coupling element holder1070 are withdrawn proximally into the left atrium, while maintainingthe distal end of central shaft 90 in place and within the ventricle.

As shown in FIGS. 9H and 9I (which is a view from the left atrium),surrounding shaft 1022 and coupling element holder 1070 are advanceddistally between leaflets 12 and 14. While the distal end of centralshaft 90 is maintained in place and within the ventricle, couplingelement holder 1070 of surrounding shaft 1022 is used to engage exactlyone of leaflets 12 and 14 with one or more of surgical hooks 164. Inorder to couple the hooks to the leaflet, if necessary the surgeon maymanipulate holder 1070. For example, the surgeon may push the holderagainst the leaflet, and/or slightly withdraw and advance the holder oneor more times. Alternatively or additionally, the natural motion of theleaflet may engage the leaflet with the hooks. It is noted that beforeand after this engagement occurs, leaflets 12 and 14 are free to openand close during the natural cardiac cycle. The reference force providedby central shaft 90 helps the holder engage the leaflet, in part becausestabilization of central shaft 90 provides a stabilized path over whichsurrounding shaft 1022 advances and withdraws. The positioning ofcoupling element holder 1070 between the leaflets, with the hooksoriented toward one of the leaflets, helps ensure that the surgicalhooks engage exactly one of the leaflets. Typically, but notnecessarily, the hooks engage the leaflet by puncturing the leaflet.

As shown in FIG. 9J, torque-delivering tool 26 (within central shaft 90)is rotated to rotate spool 46 of spool assembly 240, thereby wrappinglongitudinal members 60 and 62 around spool 46, and shortening theeffective length of the longitudinal members, as described hereinabove.This shortening has the effect of bringing the prolapsed leaflet(leaflet 14 in the figures) toward the ventricle.

Delivery tool 1020 is withdrawn from the heart, leaving implant assembly1016 implanted in the left ventricle and leaflets, as shown in FIG. 9K.Typically, screwdriver housing 28 is disengaged from spool assembly 240by gently pulling on the screwdriver housing.

For some applications of the present invention, delivery tool 1020comprises one or more return guide wires 160 and 162. The distal ends ofthe guide wires are coupled to spool assembly 240, and the proximal endsof the guide wires pass through advancement tube 1034. The guide wiresenable the surgeon to reengage delivery tool 1020 to spool assembly 240if necessary, after the delivery tool has been disengaged and withdrawnfrom the heart, as described hereinabove with reference to FIG. 9K. Toreengage, the surgeon advances screwdriver housing 28 of delivery tool1020 over the guide wires until the housing arrives at the spool, andpushes the housing onto the spool, thereby reengaging the screwdriverhousing to the housing surrounding the spool. For example, the surgeonmay decide to tighten or loosen longitudinal members 60 and 62 afterviewing images of the functioning of the valve.

Once the surgeon determines that implant assembly 1016 has been properlyimplanted and configured, guide wires 160 and 162 are decoupled fromspool assembly 240, such as by cutting (step not shown). For someapplications of the present invention, return guide wires 160 and 162comprise a single guide wire that is looped through spool assembly 240.To decouple the guide wire from the spool assembly, the surgeon releasesone end of the guide wire and pulls on the other end.

Reference is now made to FIGS. 10A-G, which are schematic illustrationsof another system for implanting and adjusting repair chords, and atranscatheter procedure for implanting the chords in a heart, inaccordance with some applications of the present invention. Except asdescribed hereinbelow, this system and procedure are similar to thesystem and procedure described hereinabove with reference to FIGS. 9A-K.

In this application of the present invention, the one or moreleaflet-engaging elements of implant assembly 1116 comprise a clip 1102.Clip 1102 typically is shaped so as to define at least one couplingprotrusion 1104. Clip 1102 has a tendency to close, and is initiallyheld open by a cord 1108 that is coupled to a surface of the clip,extends through delivery tool 1120, and is held taught outside of theheart. Once the clip has been advanced to the desired location on theleaflet, as shown in FIG. 10C, cord 1108 is relaxed, allowing the clipto close. The cord is removed, typically by releasing one end thereofand pulling the other end. The positioning of a coupling element holder1074 between the leaflets helps ensure that the clip engages exactly oneof the leaflets. It is noted that in FIG. 10G clip 1102 is shownengaging only a single leaflet (leaflet 14). The clip typically engagesthe leaflet by clamping the leaflet such that the clip engages atrialand ventricular surfaces of the leaflet. The clip may puncture theleaflet, or may merely press firmly against the leaflet.

Coupling element holder 1074 is shaped to define a groove 1100 whichhouses clip 1102 during the advancement of tool 1120 toward theventricle. Groove 1100 functions as a track to facilitate slidabledetachment of clip 1102 from holder 1074 following the engaging of clip1102 to leaflet 14.

Reference is now made to FIGS. 11A-E, which are schematic illustrationsof yet another system for implanting and adjusting repair chords, and atranscatheter procedure for implanting the chords in a heart, inaccordance with some applications of the present invention. Except asdescribed hereinbelow, this system and procedure are similar to thesystem and procedure described hereinabove with reference to FIGS. 9A-K,and the system and procedure described hereinabove with reference toFIGS. 10A-G.

In this application of the present invention, the one or moreleaflet-engaging elements of implant assembly 1116 comprise a clip 1200.Clip 1200 typically is shaped so as to define at least one couplingprotrusion 1202. Clip 1200 has a tendency to open. In order to close theclip, a cord 1208 is provided. A distal-most portion 1218 of the cord islooped around clip 1200. Once the clip has been advanced to the desiredlocation on the leaflet, as shown in FIG. 11C, the surgeon pulls on bothends of the cord, thereby causing the clip to become locked close. Thecord is removed, typically by releasing one end thereof and pulling theother end. The positioning of coupling element holder 1074 between theleaflets helps ensure that the clip engages exactly one of the leaflets.The clip typically engages the leaflet by clamping the leaflet such thatthe clip engages atrial and ventricular surfaces of the leaflet. Theclip may puncture the leaflet, or may merely press firmly against theleaflet. It is noted that in FIG. 10E clip 1102 is shown engaging only asingle leaflet (leaflet 14). For some applications of the presentinvention, longitudinal members 60 and 62 are directly coupled to clip1102, while for other applications the members are indirectly coupled,such as by a hook 1110.

Reference is now made to FIGS. 12A-G, which are schematic illustrationsof an additional system for implanting and adjusting repair chords, anda transcatheter procedure for implanting the chords in a heart, inaccordance with some applications of the present invention. Except asdescribed hereinbelow, this system and procedure are similar to thesystem and procedure described hereinabove with reference to FIGS.10A-G. In this application of the present invention, an implant assembly1316 comprises two clips 1102A and 1102B, two cords 1108A and 1108B, andtwo sets of longitudinal members 60A and 62A, and 60B and 62B, coupledto respective ones of the clips. The clips engage respective ones of theleaflets.

In some applications of the present invention, the system of FIGS. 12A-Ginstead comprises two clips 1200, as described hereinabove withreference to FIGS. 11A-E.

Reference is made to FIG. 13, which is a schematic illustration ofanother configuration of the system of FIGS. 12A-G, in accordance withsome applications of the present invention. In this configuration,implant assembly 1316 further comprises at least one bead 1340, that isthreaded over longitudinal members 60A, 62A, 60B, and 62B. The surgeonadjusts the position of the bead along the longitudinal members in orderto set the degree to which clips 1102A and 1102B are free to move withrespect to one another. Typically, the bead is pulled proximally by thedelivery tool used to implant spool assembly 240. Alternatively, thebead may be pulled by shaft 1022. In general, as the bead is positionedcloser to the clips, the clips are more constrained in their motion withrespect to one another, and the leaflets are drawn closer together. Forsome applications of the present invention, the bead comprises afixation mechanism (e.g., a crimping mechanism), which is configured tofix the bead to the longitudinal members once the bead has beenpositioned at a desire location along the members.

In some applications of the present invention, the bead of FIG. 13 isapplied to the two-clip application of the system of FIGS. 12A-G, asdescribed hereinabove.

Reference is now made to FIGS. 14A-E, which are schematic illustrationsof yet an additional system for implanting and adjusting repair chords,and a transcatheter procedure for implanting the chords in a heart, inaccordance with some applications of the present invention. Except asdescribed hereinbelow, this system and procedure are similar to thesystem and procedure described hereinabove with reference to FIGS. 9A-K.

In this application of the present invention, the one or moreleaflet-engaging elements comprise at least one non-continuous ring1400. Non-continuous ring 1400 is configured to assume extended andannular positions. In the extended position, as shown in FIG. 14A, ends1402 of the non-continuous ring are separated from one another. In theannular position, as shown in FIG. 14D, the non-continuous ring assumesan annular configuration in which ends 1402 are near one another, e.g.,within 0 mm and 1 mm, such as within 0 mm to 0.5 mm, of one another,typically separated only by tissue of the leaflet, or touching oneanother, such as end-to-end or with the ends overlapping one anotheralong the ring by up to 1 mm, such as shown in FIGS. 16A-B, describedhereinbelow. Non-continuous ring 1400 is configured to have a tendencyto assume the annular position. A delivery tool 1420 comprises adeforming rod 1440, which is configured to initially hold ring 1400 inthe extended position, as shown in FIG. 14A. For example, the ring maybe shaped so as to define one or more holes therethrough, through whichthe deforming rod passes. For some applications of the presentinvention, the deforming rod is curved (as shown), while for otherapplications, the deforming rod is straight (configuration not shown).The deforming rod protrudes from the distal end of surrounding shaft1022, and is withdrawable into the shaft.

After the anchor of spool assembly 240 has been coupled to tissue ofpapillary muscle 4, as shown in FIG. 14A, surrounding shaft 1022 iswithdrawn proximally toward leaflets 12 and 14, as shown in FIG. 14B.The non-continuous ring is positioned in the vicinity of one of theleaflets, and deforming rod 1440 is withdrawn in a proximal directioninto surrounding shaft 1022, the distal end of which pushes against oneend of the non-continuous ring, as shown in FIG. 14C. After thedeforming rod has been fully separated from the non-continuous ring, thering assumes the annular position, as shown in FIG. 14D, in which ends1402, which are generally sharp, engage the leaflet. The ends maypuncture the leaflet, or may merely press firmly against the leaflet.Also as shown in FIG. 14D, torque-delivering tool 26 (within centralshaft 90) is rotated to rotate spool 46 of spool assembly 240, therebywrapping longitudinal members 60 and 62 around spool 46, and shorteningthe effective length of the longitudinal members, as describedhereinabove. This shortening has the effect of bringing the prolapsedleaflet (leaflet 14 in the figures) toward the ventricle, as shown inFIG. 14E.

For some applications of the present invention, one of ends 1402 of thenon-continuous ring is shaped so as to define an opening, and the otherof the ends is shaped so as to at least partially enter the opening.

FIGS. 15A-C are schematic illustrations of non-continuous ring 1400 anddeforming rod 1440, in accordance with some applications of the presentinvention. As can be seen, ends 1402 of the non-continuous ring areV-shaped. Such a shape enables ring 1400 to either puncture the leafletor firmly compress a portion of the leaflet between ends 1402.

FIGS. 16A-B are schematic illustrations of another configuration ofnon-continuous ring 1400, in accordance with some applications of thepresent invention. In this configuration, ends 1402 of thenon-continuous ring are curved, such that the ends overlap one anotheralong the ring. Such a shape enables ring 1400 to either puncture theleaflet or firmly compress a portion of the leaflet between ends 1402.

Reference is now made to FIGS. 15A-C and 16A-B. For some applications ofthe present invention, rings 1400 described herein may be used as tissueanchors for other portions of tissue of the patient, e.g., the papillarymuscle of the patient. For example, ring 1400 may replace helical anchor50 of assembly 240 so as to facilitate implantation of adjustmentmechanism 40 at papillary muscle 4.

Reference is now made to FIGS. 17A-G, which are schematic illustrationsof still another system for implanting and adjusting repair chords, anda transcatheter procedure for implanting the chords in a heart, inaccordance with some applications of the present invention. Except asdescribed hereinbelow, this system and procedure are similar to thesystem and procedure described hereinabove with reference to FIGS. 9A-K.

In this application of the present invention, the one or moreleaflet-engaging elements comprise at least one butterfly clip 1500. Adistal end of a surrounding shaft 1522 is shaped so as to initially holdthe butterfly clip in a collapsed position. Petals 1523 of the butterflycomprise a superelastic material (e.g., Nitinol) that causes thebutterfly to open when released from surrounding shaft 1522.

During the transcatheter implantation procedure, as shown in FIG. 17A, adelivery tool 1520 and the implant assembly are advanced into the leftventricle. All or a portion of the delivery tool is rotated (e.g.,central shaft 90) in order to screw the helical anchor of spool assembly240 into tissue of papillary muscle 4.

As shown in FIG. 17B, surrounding shaft 1522 is withdrawn proximallytoward the left atrium, while maintaining the distal end of centralshaft 90 in place and within the ventricle. At this step of theprocedure, butterfly clip 1500 remains in the ventricle.

As shown in FIG. 17C, one or more stiff cords 1524 that pass throughsurrounding shaft 1522 push the butterfly clip out of the distal end ofthe shaft and against the ventricular surface of one of the leaflets, sothat the butterfly clip penetrates the ventricular surface and emergesfrom the atrial surface of the leaflet. The butterfly clip typicallycomprises a sharp needle 1526 to aid with this penetration. As shown inFIG. 17D, upon emerging from the atrial surface, the butterfly clip,because of its superelastic properties, unfolds, thereby coupling theclip to the leaflet.

As shown in FIG. 17E, torque-delivering tool 26 (within central shaft90) is rotated to rotate spool 46 of spool assembly 240, therebywrapping longitudinal members 60 and 62 around spool 46, and shorteningthe effective length of the longitudinal members, as describedhereinabove. This shortening has the effect of tightening butterfly clip1500 against the atrial surface of the leaflet (as shown in FIG. 17F),and bringing the prolapsed leaflet (leaflet 14 in the figures) towardthe ventricle.

Delivery tool 1520 is withdrawn from the heart, leaving the implantassembly implanted in the left ventricle and leaflet, as shown in FIG.17K.

Reference is now made to FIGS. 18A-D, which are schematic illustrationsof yet another system for implanting and adjusting repair chords, and atranscatheter procedure for implanting the chords in a heart, inaccordance with some applications of the present invention. Except asdescribed hereinbelow, this system and procedure are similar to thesystem and procedure described hereinabove with reference to FIGS. 9A-K.

In this application of the present invention, the one or moreleaflet-engaging elements comprise at least one clip 1600 that comprisestwo jaws 1602A and 1602B, which are configured to assume a closedposition when in a resting state. For example, clip 1600 may comprise aspring configured to close the jaws (spring not shown in figures). Acoupling element holder 1674 of surrounding shaft 1022 comprises arestraining element 1676 that is configured to hold the jaws separatedand the clip in an open position. For some applications of the presentinvention, the restraining element is positioned between thenon-coupling ends of the jaws beyond the pivot. Pushing restrainingelement 1676 away from the jaws releases the jaws, allowing them toassume their resting closed position. For example, the restrainingelement may be configured to be pushed in a distal direction, as shownin FIG. 18B, such as by a rod 1678.

Reference is now made to FIGS. 19, 20A-B, and 21 which are schematicillustrations of respective systems for repairing malpositioning of thewall of the ventricle of the patient, in accordance with respectiveapplications of the present invention. FIG. 19 is a schematicillustration of heart 2 in a weakened state in which the wall of theleft ventricle is malpositioned and weakened. As a result, leaflets 12and 14 of mitral valve 8 are malpositioned and are distanced from oneanother.

FIG. 20A shows system 600 comprising spool assembly 240 implanted at afirst portion 420 of heart tissue which faces and surrounds the leftventricle of heart 2. First implantation site 5 thus comprises firstportion 420 of heart tissue. Spool assembly 240 is implanted via tool 20at site 5 in a manner as described hereinabove with reference to FIGS.5A-G. The free ends of longitudinal members 60 and 62 are coupled to asecond portion 422 of heart tissue which faces and surrounds the leftventricle of heart 2. Second implantation site 7 thus comprises secondportion 422 of heart tissue, e.g., at the septum, by way of illustrationand not limitation. The free ends of longitudinal members 60 and 62 arecoupled to the heart tissue using any suitable attachment means 602,e.g., sutures, knotting, or tissue anchors such as helical anchors.Spool 46 of adjustment mechanism 40 is rotated by tool 20, as describedhereinabove, thereby pulling tight longitudinal members 60 and 62 andthereby reducing a length of longitudinal members 60 and 62 betweenfirst and second implantation sites 5 and 7. In response to the pullingof longitudinal members 60 and 62, first and second portions 420 and 422of the heart tissue are pulled toward one another, and a length oflongitudinal members 60 and 62 is adjusted. Consequently, the dimensionsof the heart wall are restored to physiological dimensions, and leaflets12 and 14 are drawn toward one another.

FIG. 20B shows system 700 for adjusting a distance between two portionsof a heart wall of the left ventricle of the patient. Longitudinalmembers 60 and 62 are coupled at first portions thereof to spool 46 ofadjustment mechanism 40. Respective free ends of each member 60 and 62are coupled to opposing first and second portions of the heart wallwhich faces and surrounds the ventricular lumen of heart 2. The free endof longitudinal member 62 is coupled to first implantation site 5 usinga first helical anchor 750 by way of illustration and not limitation.For example, the free end of longitudinal member 62 is coupled to firstimplantation site 5 using sutures, knots, or any tissue anchor known inthe art. The free end of longitudinal member 60 is coupled to secondimplantation site 7 using a second helical anchor 750 by way ofillustration and not limitation. For example, the free end oflongitudinal member 60 is coupled to second implantation site 7 usingsutures, knots, or any tissue anchor known in the art. In such aconfiguration, adjustment mechanism 40 is disposed between longitudinalmembers 60 and 62 and is not directly coupled to heart tissue.

Following the attaching of longitudinal members 60 and 62 toimplantation sites 5 and 7, respectively, spool 46 of adjustmentmechanism 40 may be rotated using tool 20, or any other transcathetertools described herein, in a manner as described hereinabove. Asdescribed hereinabove, using tool 20, spool 46 of adjustment mechanism40 is rotated in order to adjust a distance between first and secondimplantation sites 5 and 7. Responsively, the first and second portionsof the ventricle wall are drawn together. Consequently, the dimensionsof the heart wall are restored to physiological dimensions, and leaflets12 and 14 are drawn toward one another.

FIG. 21 is a schematic illustration of a system 800 for adjusting adistance between two portions of a heart wall of the left ventricle ofthe patient. System 800 comprises a tensioning device 802 coupled at afirst end thereof to spool assembly 240. In a manner as describedhereinabove, using tool 20, spool assembly 240 is implanted at firstimplantation site 5 in a first portion of tissue of the heart wall thatfaces and surrounds the ventricular lumen. The free end, i.e., secondportion, of tensioning device 802 is attached at second implantationsite 7 to a second portion of tissue of the heart wall that faces andsurrounds the ventricular lumen. The free end of tensioning device 802is implanted in heart tissue using a helical anchor by way ofillustration and not limitation. For example, the free end of tensioningdevice 802 may be coupled to second implantation site 7 using sutures,knots, or any tissue anchor known in the art.

Tensioning device 802 comprises a flexible material, e.g., ePTFE ornitinol, and is shaped to define a coiled portion 806 that has a lengthof between 20 mm and 50 mm and a diameter of between 0.5 mm and 3.0 mm.Tensioning device 802 comprises wire/suture portions 804 on either sideof coiled portion 806.

As described hereinabove, using tool 20, spool 46 of adjustmentmechanism 40 is rotated in order to adjust a distance between first andsecond implantation sites 5 and 7. As spool 46 is rotated in a firstdirection thereof, suture portion 804 that is disposed adjacently tospool assembly 240 is wrapped around spool 46. Tensioning device 802 istightened and shortened in response to the wrapping of portion 804around spool 46. As device 802 is tightened, a force is applied tocoiled portion 806 of tensioning device 802. Coiled portion 806 appliesa supplemental puling force to help pull the opposing first and secondportions of the ventricle wall, toward one another. Consequently, thedimensions of the heart wall are restored to physiological dimensions,and leaflets 12 and 14 are drawn toward one another.

Reference is again made to FIGS. 19-20. It is to be noted that the scopeof the present invention includes the use of systems 600, 700, and 800for adjusting a distance between any two portions of the heart and notjust opposing portions, as described hereinabove. For example, first andsecond implantation sites 5 and 7 may be on the same side, e.g., theseptum, of the wall of the heart.

Reference is now made to FIGS. 22A-C which are schematic illustrationsof a system 900 for drawing together leaflets 12 and 14 of a mitralvalve of the patient, in accordance with some applications of thepresent invention. Spool assembly 240 is implanted in first implantationsite 5 at papillary muscle 4 of the left ventricle by way ofillustration and not limitation. For example, spool assembly 240 may beimplanted in a portion of the heart wall of the ventricle, e.g., thebase of the papillary muscle. As described hereinabove, respective firstportions of each longitudinal member 60 and 62 are coupled to spool 46of adjustment mechanism 40. The free end, i.e., second portion, oflongitudinal member 60 is coupled, e.g., sutured, anchored, clipped,locked in place with a crimping bead 918, to leaflet 12 at animplantation site 902. The free end, i.e., second portion, oflongitudinal member 62 is coupled, e.g., sutured, anchored, clipped,locked in place with a crimping bead 918, to leaflet 14 at animplantation site 904.

As described hereinabove, using tool 20, spool 46 of adjustmentmechanism 40 is rotated in order to adjust a length of longitudinalmembers 60 and 62. As shown in FIG. 22B, longitudinal members 60 and 62are pulled tight in response to rotation of spool 46 in a firstdirection thereof. In response to the pulling of longitudinal members 60and 62 leaflets 12 and 14 are pulled toward one another in order torestore coaptation to valve 8.

It is to be noted that system 900 may be used on the tricuspid valve.

In some applications of the present invention, spool assembly 240 iscoupled to first implantation site, e.g., papillary muscle 4, to thebase of the papillary muscle, or to any suitable portion of heart tissuefacing and surrounding the ventricle. In such some applications:

(1) the free end of longitudinal member 60 is coupled to, e.g., suturedto or anchored to, a second implantation site (e.g., another portion ofthe inner wall of the heart that faces and surrounds the ventricle),

(2) the free end of longitudinal member 62 is coupled to, e.g., suturedto or anchored to, a third implantation site (e.g., yet another portionof the inner wall of the heart that opposes the portion of tissue towhich the free end of longitudinal member 60 is coupled), and

(3) rotation of spool 46 draws the first, second, and third implantationsites toward one another.

In some applications of the present invention, system 900 may be used toprovide adjustable artificial chordeae tendineae as well as drawtogether portions of the inner wall of the ventricle, i.e., the portionof the heart tissue which surrounds and faces the ventricular lumen. Insuch some applications of the present invention, longitudinal member 60is coupled at a first end thereof to spool 46 and at a second endthereof to a leaflet of the atrioventricular valve. Longitudinal member62 is coupled at a first end thereof to spool 46 and at a second endthereof to a portion of tissue of the inner wall of the ventricle. Asdescribed hereinabove, spool assembly 240 is implanted at firstimplantation site 5 (e.g., papillary muscle 4, as shown, or any othersuitable portion of tissue of the inner wall of the ventricle). Inresponse to rotation of spool 46 of adjustment mechanism, both theleaflet and the portion of tissue of the inner wall of the ventricle arepulled toward spool assembly 240 at implantation site 5.

In the configuration of system 900 shown in FIG. 22C, the implantassembly further comprises at least one bead 940, that is threaded overlongitudinal members 60 and 62. The surgeon adjusts the position of thebead along the longitudinal members in order to set the degree to whichthe free ends of the longitudinal members are free to move with respectto one another. In general, as the bead is positioned closer to thevalve, the free ends of the longitudinal members are more constrained intheir motion with respect to one another, and the leaflets are drawncloser together. For some applications of the present invention, thebead comprises a fixation mechanism (e.g., a crimping mechanism), whichis configured to fix the bead to the longitudinal members once the beadhas been positioned at a desire location along the members.

Reference is now made to FIG. 23, which is a schematic illustration of asystem 950 that is similar to system 900 as described hereinabove withreference to

FIGS. 22A-C, with the exception that bead 940 is pulled adjacently tothe ventricular surfaces of leaflets 12 and 14, in accordance with someapplications of the present invention. As shown, spool assembly 240 isimplanted at the base of papillary muscle 4 at implantation site 5.Pulling bead 940 adjacently to leaflets 12 and 14 creates a firmcoupling of the leaflets at the middle portion of mitral valve 8, asshown in Section A-A. The firm coupling of leaflets 12 and 14 preventsprolapsing of leaflets 12 and 14, facilitates coaptation of leaflets 12and 14, and creates openings 962 and 964 in mitral valve 8 so as tofacilitate blood flow from the atrium to the ventricle.

Reference is now made to FIGS. 24A-I, which are schematic illustrationsof yet another system for implanting and adjusting repair chords, and atranscatheter procedure for implanting the chords in a heart, inaccordance with some applications of the present invention. Except asdescribed hereinbelow, this system and procedure are similar to thesystem and procedure described hereinabove with reference to FIGS. 9A-K.

In this application of the present invention, the one or moreleaflet-engaging elements comprise at least one clip 1600 that comprisestwo clip jaws 1602A and 1602B, which are configured to grasp and engagea leaflet, using one or more anchoring spikes on the clips. A couplingelement holder 1670 comprises two tool jaws 1604A and 1604B. Prior todeployment, clip 1600 is held within the tool jaws of the couplingelement holder, with clip jaws 1602A and 1602B aligned with andpartially covering tool jaws 1604A and 1604B, respectively, as shown inFIGS. 24B and 24C. The tool jaws and clip jaws are shown in a closedposition in FIG. 24B. Coupling element holder 1670 is advanced into theleft ventricle in this position. Subsequently, as shown in FIG. 24C, thetool jaws are opened, such as by moving tool jaw 1604A using an actuator1606. Opening of the tool jaws opens the clip jaws.

As shown in FIG. 24D, coupling element holder 1670 is withdrawnproximally towards leaflets 12 and 14. The open clip jaws are positionedin a vicinity of one of the leaflets (for example, leaflet 14, as shownin the figure). In order to engage the leaflet with clip 1600, as shownin FIG. 24E, if necessary the surgeon may manipulate the couplingelement holder (e.g., to push the clip against the leaflet, and/orslightly withdraw and advance the holder one or more times).Alternatively or additionally, the natural motion of the leaflet mayengage the leaflet with the clip. It is noted that before and after thisengagement occurs, the leaflets are free to open and close during thenatural cardiac cycle. The clip jaws are closed onto the leaflet byclosing the tool jaws. Typically, a safety pin 1608 (shown most clearlyin FIG. 24I) locks the clip jaws closed.

As shown in FIG. 24F, clip 1600 is released from the tool jaws, such asby using an clip release actuator 1610 (shown in FIG. 24I). Couplingelement holder 1670 is then withdrawn from the ventricle. As shown inFIG. 24G, torque-delivering tool 26 (within central shaft 90) is rotatedto rotate spool 46 of spool assembly 240, thereby wrapping longitudinalmembers 60 and 62 around spool 46, and shortening the effective lengthof the longitudinal members, as described hereinabove. Delivery tool1620 is withdrawn from the heart, leaving implant assembly 1616implanted in the left ventricle and leaflets, as shown in FIG. 24H.

FIG. 24I is a schematic illustration of the components of clip 1600 anda distal portion of coupling element holder 1670, in accordance withsome applications of the present invention. For clarity of illustration,the components are shown disassembled.

Reference is now made to FIGS. 1-24I. It is to be noted that theshortening of longitudinal members 60 and 62 described herein isreversible. That is, rotating spool 46 in a rotational direction thatopposes the rotational direction used to shorten the longitudinalmembers, unwinds respective portions of the longitudinal members fromaround spool 46. Unwinding the portion of the longitudinal members fromaround spool 46 thus slackens the remaining portions of the longitudinalmembers that are disposed between first and second implantation sites 5and 7. Responsively, the longitudinal members are elongated (i.e., withrespect to their shortened states state prior to the unwinding).

Reference is yet again made to FIGS. 1-24I. It is to be noted thatfollowing initial adjustment of the repair chords, the repair chords maybe further adjusted at a later state following the initial implantationthereof. Using real-time monitoring, tactile feedback and optionally incombination with fluoroscopic imaging, tool 20 may be reintroducedwithin the heart and engage spool 46.

It is to be noted that systems 10, 400, 500, 900, and 950 may be used asartificial chordeae tendineae to replace stretched native chordeaetendineae of a left ventricle or of a right ventricle. For someapplications of the present invention, spool assembly 240 is coupled tothe papillary muscle. For some applications of the present invention,spool assembly 240 is coupled to a portion of the wall of theventricular lumen.

It is to be noted that systems 600, 700, and 800 may be may be used inorder to repair malposition of portions of the wall of a left ventricleor of a right ventricle.

Reference is still yet again made to FIGS. 1-24I. It is to be noted thatfirst implantation site 5 may be any portion of tissue that faces andsurrounds the ventricle of the heart of the patient. For example, firstimplantation site 5 may include a first portion of tissue of an innerwall of the ventricle at the base of the papillary muscle or any othersuitable location along the inner wall. First implantation site 5 mayalso include tissue of the papillary muscle. It is to be noted thatsecond implantation site 7 may be any portion of tissue that faces andsurrounds the ventricle of the heart of the patient. For example, secondimplantation site 7 may include a second portion of tissue of an innerwall of the ventricle at the septum, or any other suitable locationalong the inner wall. Second implantation site 7 may also include aleaflet of an atrioventricular valve of the heart of the patient.

Reference is still yet again made to FIGS. 1-24I. It is to be noted thatsystems described herein may be used to repair the heart duringopen-heart, minimally-invasive, and transcatheter procedures. Forapplications in which delivery tool 20 is introduced within the heartduring minimally-invasive and transcatheter procedures, shaft 22,torque-delivering tool 26, and overtube 90 are longer than as shownhereinabove. For such applications, suture needle 64 coupled to thelongitudinal member is coupled to needle holder 70 of tool 20 in amanner in which needle 64 faces outward. In such a configuration, thepiercing portion, e.g., a barbed portion, of needle 64 is exposed fromslit 72 of holder 70. In such some applications of the presentinvention, needle holder 70 may be coupled to a distal portion of shaft22.

For transcatheter procedures, delivery tool 20 is advanced toward theheart through an advancement catheter, e.g., a 12-13 F catheter. Theadvancement catheter facilitates atraumatic advancement of tool 20through vasculature of the patient by providing an overtube which coversthe outwardly-facing needle 64 of tool 20.

The advancement catheter is positioned in the heart in a manner in whicha distal end thereof is disposed within the ventricle of the patient anda portion of the advancement catheter extends between the leaflets ofthe atrioventricular valve of the patient. Tool 20 is advanced throughthe advancement catheter until a distal end thereof is disposed in thevicinity of first implantation site 5 and subsequently facilitates theimplantation of spool assembly 240 in tissue of the ventricle at firstimplantation site 5. Following the implantation of spool assembly 240 infirst implantation site 5, the advancement catheter and multilumen shaft22 are retracted proximally such that the distal-most ends of theadvancement catheter and shaft 22 are disposed proximally to theatrioventricular valve. The advancement catheter is retracted further inorder to expose the outwardly-facing needle 64 from within theadvancement catheter. Delivery tool 20 is then manipulated, e.g., pushedlaterally, such that the piercing portion, e.g., the barbed portion, ofneedle 64 is disposed adjacently to and punctures a leaflet of theatrioventricular valve. The barbed portion remains disposed coupled tothe leaflet, and thereby the second portion of the longitudinal memberis coupled to the leaflet.

Spool assembly 240 is then adjusted in a manner as described hereinabovein order to adjust a distance between the second portion of thelongitudinal member and spool assembly 240, and thereby create at leastone adjustable artificial chordea tendinea that resembles the nativechordea tendinea. Following the adjusting of the longitudinal member,delivery tool 20 is decoupled from spool assembly 240, as describedhereinabove, and tool 20 and the advancement catheter are extracted fromwithin the body of the patient.

Reference is still yet again made to FIGS. 1-24I. It is to be noted thatspool housing 42 and spool 46 may be implanted in a first portion oftissue of the heart independently of tool 20 and tissue anchor 50. Insuch some applications of the present invention, spool housing 42 issutured to tissue of the ventricle. Prior to implantation of housing 42,a longitudinal member is coupled to, e.g., knotted to, welded to, loopedthrough, spool 46 at a first portion thereof. The second portion ofspool 46 is coupled to, e.g., knotted to, sutured to, or anchored to, asecond portion of tissue of the heart. Spool 46 may be rotated using anysuitable screwdriver or screwdriver head 95, as described hereinabove.

Reference is still yet again made to FIGS. 1-24I. Spool 46 may becoupled to the heart tissue in a manner in which a central longitudinalaxis through spool 46 forms an angle with a surface of the heart tissueof between about 30 and 180 degrees, e.g., between about 75 and 90degrees, such as about 90 degrees. In some applications of the presentinvention, spool 46 is coupled to the heart tissue in a manner in whichthe central longitudinal axis is parallel with the surface of the hearttissue.

Although the techniques described herein are generally described asbeing performed on the left ventricle and/or mitral valve, the techniquemay also be performed on the right ventricle and/or tricuspid valve.Additionally, techniques described herein may be used during open-heart,minimally-invasive, and transcatheter procedures, mutatis mutandis.

It is to be noted that the scope of the present invention includes theapplication of adjusting a length of the artificial chords followinginitial implantation (i.e., once the delivery tools have been extractedfrom within the body) in response to the application of energy (e.g.,radiofrequency or ultrasound) toward the heart from a source of energydisposed externally to the body of the patient.

For some applications of the present invention, techniques describedherein are practiced in combination with techniques described in one ormore of the references cited in the Background section andCross-references section of the present patent application.

As appropriate, techniques described herein are practiced in conjunctionwith methods and apparatus described in one or more of the followingpatent applications, all of which are assigned to the assignee of thepresent application and are incorporated herein by reference:

-   -   PCT Patent Application PCT/IL07/001503 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as WO 08/068756;    -   U.S. patent application Ser. No. 11/950,930 to Gross et al.,        entitled, “Segmented ring placement,” filed on Dec. 5, 2007,        which published as US Patent Application Publication        2008/0262609, and which issued as U.S. Pat. No. 8,926,695;    -   U.S. Provisional Patent Application 61/132,295 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed on Jun. 16, 2008;    -   U.S. patent application Ser. No.12/341,960 to Cabiri, entitled,        “Adjustable partial annuloplasty ring and mechanism therefor,”        filed on Dec, 22, 2008, which published as US 2010/0161047, and        which issued as U.S. Pat. No. 8,241,351;    -   U.S. Provisional Patent Application 61/207,908 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed on Feb. 17, 2009;    -   U.S. patent application Ser. No.12/435,291 to Maisano et al.,        entitled, “Adjustable repair chords and spool mechanism        therefor,” filed on May 4, 2009, which published as US        2010/0161041, and which issued as U.S. Pat. No. 8,147,542;    -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        entitled, “Annuloplasty ring with intra-ring anchoring,” filed        on May 7, 2009, which published as US 2010/0286767, and which        issued as U.S. Pat. No. 8,715,342;    -   PCT Patent Application PCT/IL2009/000593 to Gross et al.,        entitled, “Annuloplasty devices and methods of delivery        therefor,” filed on Jun. 15, 2009, which published as WO        10/004546;    -   U.S. patent application Ser. No. 12/548,991 to Maisano et al.,        entitled, “Implantation of repair chords in the heart,” filed on        Aug. 27, 2009, which published as US 2010/0161042, and which        issued as U.S. Pat. No. 8,808,368;    -   U.S. patent application Ser. No. 12/608,316 to Miller et al.,        entitled, “Tissue anchor for annuloplasty ring,” filed on Oct.        29, 2009, which published as US 2011/0106247, and which issued        as U.S. Pat. No. 8,277,502;    -   U.S. Provisional Patent Application 61/265,936 to Miller et al.,        entitled, “Delivery tool for implantation of spool assembly        coupled to a helical anchor,” filed Dec. 2, 2009;    -   PCT Patent Application PCT/IL2009/001209 to Cabiri et al.,        entitled, “Adjustable annuloplasty devices and mechanisms        therefor,” filed on Dec. 22, 2009, which published as WO        10/073246;    -   U.S. patent application Ser. No. 12/689,635 to Zipory et al.,        entitled, “Over-wire rotation tool,” filed on Jan. 19, 2010,        which published as US 2010/0280604, and which issued as U.S.        Pat. No. 8,545,553;    -   U.S patent application Ser. No. 12/689,693 to Hammer et al.,        entitled, “Application Deployment techniques for annuloplasty        ring,” filed on Jan. 19, 2010, which published as US        2010/0280605, and which issued as U.S. Pat. No. 8,911,494;        and/or    -   U.S. patent application Ser. No. 12/706,868 to Miller et al.,        entitled, “Actively-engageable movement-restriction mechanism        for use with an annuloplasty structure,” filed on Feb. 17, 2010,        which published as US 2010/0211166, and which issued as U.S.        Pat. No. 8,353,956.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. A method, comprising: implanting a firstlongitudinal repair member in a ventricle of a heart of a patient, bycoupling a first portion of the first longitudinal repair member to afirst leaflet of a valve of the heart of the patient and by coupling asecond portion of the first longitudinal repair member to tissuesurrounding the ventricle; implanting a second longitudinal repairmember in the ventricle of the heart of the patient, by coupling a firstportion of the second longitudinal repair member to a second leaflet ofthe valve of the heart of the patient and by coupling a second portionof the second longitudinal repair member to tissue surrounding theventricle; and advancing, toward a ventricular surface of the valve, alongitudinal-member-coupling device that is coupled to the first andsecond longitudinal members between the first and second portions of therespective first and second longitudinal members, and by the advancingdrawing together the first and second leaflets in a middle portion ofthe valve.
 2. The method according to claim 1, wherein advancingcomprises, by the advancing, creating first and second openings in thevalve on either side of the middle portion for blood flow through theopenings.
 3. The method according to claim 1, wherein the method furthercomprises adjusting a degree of tension of the first and secondlongitudinal members to adjust a degree of coupling between the firstand second leaflets.
 4. The method according to claim 3, whereinadjusting the degree of tension comprises adjusting the degree oftension of the first and second longitudinal members using at least onelongitudinal-member-adjusting mechanism coupled to respective secondportions of the first and second longitudinal members.